Upload
fda
View
215
Download
0
Embed Size (px)
Citation preview
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 1/28
00.2 [1] 286:3
0.4 [1] 286:1
0.9 [1] 33:7
0.997 [1] 35:9
0.999 [1] 58:15
11 [44] 20:18 31:6,18 33:12 38:21 58:
21 66:9 69:4,17 72:2 73:18 109:9
111:16,17 113:10 114:4 143:1156:19 174:16 178:6 199:1 202:4
231:17 240:13 244:20,21,21 245:
7,10 247:4,5,6,12,16 249:5,12 250:
14 251:2,13 252:12,17,21 304:4
306:19
1,700 [1] 228:13
1.a [1] 258:6
1:05 [1] 171:12
10 [6] 19:6 101:7 104:5 117:22 217:
11 228:16
10,000 [2] 10:21 18:16
10-20 [1] 49:1
10-30 [1] 74:4
10:35 [1] 106:4
100 [14] 30:19 31:20 35:8 43:19 65:
10 87:9 120:21 123:10,20 127:2
231:11 247:14 248:22 269:7
102 [1] 236:4
1029 [1] 49:5
103 [1] 236:4
106 [1] 3:25
11 [2] 20:3 49:5
12 [27] 17:17 19:7 40:18 41:5 65:10,
19 91:19 99:21,22 116:2,7 121:20,
21 122:2,5 132:21 133:1 163:17
164:6 166:22 228:16 263:7 264:6
286:2,4 300:14 301:4
12-week [6] 40:16 64:16 92:3 168:
22 169:9 261:1412-year [1] 298:1
12:00 [1] 171:11
120 [1] 33:9
12A-30 [1] 8:6
13 [1] 310:10
13,500 [1] 217:1
14 [5] 34:18 36:13 133:13 298:17
301:4
14-29 [1] 240:13
14-year [3] 299:9,11 300:2
142 [1] 3:26
15 [11] 12:16 45:2 107:1,13 109:22
129:10 146:7,8 151:12 204:14
298:1715,000 [1] 87:7
15-20 [1] 88:2
15-minute [1] 257:22
150,000 [1] 86:13
16 [2] 3:13 166:22
17 [1] 46:13
17,000 [2] 79:3 216:22
170 [1] 108:10
174 [1] 3:28
18 [2] 148:14,15
18-gauge [1] 67:17
180 [1] 3:29
186 [1] 3:30
19 [2] 1:7 187:2
191 [1] 3:31
197 [1] 3:32
1980 [1] 50:1
1980s [1] 174:7
1985 [1] 191:5
1987 [1] 23:15
1992 [1] 23:19
1995 [2] 84:14 85:3
1996[1]
86:41997 [1] 216:20
22 [27] 37:1 38:22 46:14 58:20 66:11
67:5 69:3 73:18 94:20 109:10 114:
21 125:5 143:1 148:19 156:20
157:20 202:11 244:21,21 245:6,7
247:6 248:14,19 249:6,10 250:13
20 [7] 84:13 92:18 101:7 104:5 181:
22 204:14 313:2
20-25 [1] 66:10
20-27 [1] 64:9
20-30 [4] 54:3 57:2 74:5 274:17
200 [4] 11:2 21:7 108:10 201:2
200-250 [1] 286:72003 [1] 22:6
2004 [1] 153:20
2006 [3] 1:7 287:19 313:3
2009 [1] 168:11
2010 [1] 49:5
208,500 [1] 49:1
20s [1] 204:12
21 [1] 49:6
22 [3] 127:21 187:2 262:22
23 [2] 84:13 306:17
24 [27] 15:6 39:11 58:20 65:10 70:
11 100:7 109:10 116:3 118:9 119:
3 120:21 121:4,9,21 122:1 139:15,
16 143:2 155:11 156:19,21 157:
19,22 159:12 162:18 168:17 252:
13
24-week [4] 63:18 155:11 156:3
157:1
25-plus [1] 87:7
25-year [2] 298:2 300:2
26 [1] 50:1
2b [1] 97:6
33 [28] 12:20 38:22 58:20 66:12 69:3
73:18 101:8 109:10 114:21 143:2
148:20 156:20 157:20 167:5,11
202:11 244:21,22 245:6,7 247:6
248:3,3,14,19 249:7,10 250:133.2 [1] 22:13
3.4 [1] 23:8
3:00 [1] 237:22
30 [3] 37:19 117:20 199:11
30-80 [2] 109:14 199:1
300 [2] 34:4 301:4
300-400 [1] 58:16
33 [1] 310:9
35 [1] 17:18
35-40 [1] 204:11
36 [1] 128:5
3A4 [2] 227:15 230:5
44 [31] 3:4 20:20 21:8 70:9 72:1 73:
18 109:9 111:16 114:14 123:7,11
156:19 163:17 164:6 167:6,11,12
169:8 202:4,5,8 244:21,21 245:7,
10,14,16,20 246:13 247:5,20
4-12 [1] 118:16
4-8 [1] 37:18
4-week [1] 40:5
4.1 [1] 22:8
4.7 [1] 23:7
4:25 [1] 313:1
40 [2] 117:20 164:22
40,000 [1] 10:17
40-50 [2] 113:15 199:6
400 [3] 34:2,4 301:3
48 [11] 58:21 72:1 109:9 118:9 143:
2 155:10 156:19 168:17 192:13
252:12,21
48-week [2] 40:2 162:18
55 [1] 17:19
5-10 [1] 136:8
5-7 [2] 74:7 274:18
5-prime [1] 18:17
5.1 [1] 23:8
50 [8] 3:19 55:2 72:7 117:10 120:
21 123:8,11 238:10
50-60 [1] 174:16
50-70 [1] 231:18
500-600 [1] 20:22
5071 [1] 310:7
54 [1] 17:18
55-year [1] 299:10
56 [1] 35:1
66 [2] 3:6 20:19
60 [1] 31:860-plus [1] 286:22
600 [2] 33:21 255:21
600-700-day [1] 162:7
64 [1] 34:22
77,200 [1] 216:20
7-14-day [1] 103:11
70 [3] 31:8 299:8,10
70-75 [1] 66:8
72 [4] 32:16 35:18 40:11 155:13
72-week [1] 156:3
8
8,000-10,000[1]
22:148:00 [3] 1:8 312:4 313:3
80 [8] 71:7,8,9 87:8 116:9 176:1
191:21 199:11
80-80-80 [3] 71:13 237:9 254:12
800,000 [1] 69:6
800-1000 [1] 301:5
83 [1] 3:22
85 [4] 53:15 247:11,14 248:21
99 [1] 3:10
90 [5] 31:9 33:7,20,20 311:11
900 [2] 86:7,8
95 [2] 75:21 136:1
97-99 [1] 175:17
98 [3] 64:15 65:9 121:18
99 [1] 33:8
99.9 [2] 31:9 34:1
99.99 [1] 34:2
>>90s [1] 174:14
]]s [1] 44:21
AA-2-ALL [1] 152:8
a.m [2] 312:4 313:3
Aadult@ [1] 299:17
Aall [1] 296:18AASLD [1] 116:19
Abbott [2] 6:1 8:19
abbreviations [1] 70:18
abide [1] 219:16
ability [15] 19:9 33:4 52:21 53:3 56:
2 70:21 71:6 75:19 78:22 183:1
228:18 277:19,21 286:12 299:3
able [25] 12:3 30:5 40:8,9 105:3,15
112:9 149:18 150:22 163:16 167:
17,19 168:2 169:17,18 174:13
176:19 198:5 208:21 245:15 278:
15 280:3 302:10 304:2 305:2
abnormal [1] 26:16abnormalities [2] 188:10,11
abort [1] 274:15
aboutB-all [1] 110:14above [1] 125:18
Aboy [1] 37:7
absence [5] 75:4,10 76:8 78:6 80:
5
absolute [6] 200:4 220:8 230:20
232:2 252:7 281:6absolutely [9] 50:5 162:20 223:19
231:6 252:14 254:9 283:20 306:
22 307:4
abuse [1] 189:7
abusers [2] 99:3,4
academic [2] 7:10 309:22
academics [1] 191:3
accelerate [2] 96:7 217:5
accelerated [5] 74:2 93:14,19 224:
13 274:15
accelerating [2] 96:12 150:15
acceleration [1] 224:22
accept [2] 252:15 265:8
acceptable [7] 118:13,15 119:11,
13,17,21 138:19
accepted [1] 251:21
access [12] 8:2 85:5,12 90:14 93:
13,19 94:2 96:21 114:21 205:16
207:4 225:8
accordingly [1] 30:10
account [4] 43:7 247:19 249:16
306:12
accounting [1] 75:21
accrual [1] 308:21accrued [1] 206:10
accumulation [1] 81:7
Sheet 1 0.2 - accumulation
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 2/28
accuracy [1] 67:13
accurate [2] 23:5 124:14
achieve [25] 39:13 40:17 41:4 48:
6 62:5 65:7,21 67:5 71:7,12 77:22
80:5 116:1 118:1 128:1 137:2 141:
17 154:5 174:21 184:4 274:6,12
279:7 302:10,17
achieved [8] 56:18 80:3 83:10
120:10 127:21 128:5,12 163:9
achievement [1] 128:7
achieving[2]
69:2 75:8acid [1] 277:20
acknowledge [3] 9:17 108:11
154:22
acknowledges [1] 8:8
acquainted [1] 87:12
acquired [2] 287:1 290:6
acquiring [1] 279:9
across [7] 19:15 36:4 37:10 122:5
188:17 257:14 275:4
Act [5] 88:16 89:3,3 185:1 222:7
ACTG [3] 84:15 105:13 310:7
Acting [3] 2:2 3:4 8:15
Action [9] 5:4 32:13 51:11 59:3 62:
3 133:10 181:11 183:13 185:9
activation [1] 53:2active [10] 23:8 73:3 75:4 77:8 78:
7 118:14 144:5 180:11 260:1 312:
16
actively [2] 215:2 217:1
activity [7] 68:14 132:14 133:13
140:20 161:15 245:6 298:7
actual [6] 34:9,20 35:12,18 39:19277:4
actually [60] 20:1 29:6 34:17 35:4,
9,13,17,21 37:1 41:17 55:16 61:
16 65:19 67:20 68:18 84:17 85:2,
5 90:5 106:15 120:19 134:14 146:
15,19 147:10 150:13 152:14 153:
15 154:14 155:5 156:6 158:2,6160:14 172:9 175:19 182:1,6,11
194:8 205:6 206:7 213:21 214:5
215:1,5,6 220:6,18 238:7,14 241:
15 247:3 248:13 250:4 281:10
286:5 292:19 299:18,22
Acure@B-for [1] 84:22
acute [6] 22:6 26:4 45:4 50:22 181:
21 183:3
acutely [2] 182:1,16
adapt [1] 277:11
adaptable [1] 280:21
adapted [1] 278:2
adaptive [1] 60:8
adapts [1] 19:14
adazanovir [1] 301:3add [14] 14:13 130:21 152:1 158:4
176:9 224:21 225:4 228:1 235:4
240:20 281:16 282:2 301:10 307:
17
add-on [2] 159:14 262:6
added [4] 31:6 169:9 264:17 269:7
adding [12] 14:10 129:21 130:2
131:15 132:1 140:14 159:13 171:
2 179:8 193:11 252:12 255:14
addition [14] 4:14 8:4 130:20 160:
21 179:5 195:20 215:22 221:2,5
233:3 246:2 252:22 275:11,17
additional [10] 16:5 48:4 146:4
168:4,5,11 232:9 273:12 274:5
312:5
Additionally [1] 187:20
additive [1] 132:19
address [19] 9:4 70:3,4 95:19 142:
7,20 143:18 173:9 184:13 185:22
193:22 196:4 197:14 208:9 258:2
271:19 273:21 290:10 303:22
addressed[7]
88:20 185:6 190:10193:18 195:15 209:21 304:19
addresses [2] 6:15 70:8
addressing [4] 17:13 90:1 181:12
224:2
adds [3] 28:5 59:21 256:16
Adefovir [1] 272:19
adequacy [1] 170:22
adequate [16] 67:9,12 70:21 91:7
92:9,22 93:6 104:2 164:6 191:21
245:19 246:12 260:6,7 263:13,18
adequately [3] 98:16 195:12 305:
21
adherence [2] 71:4 266:21
adjourn [2] 171:10 312:3
adjourned [1] 313:2adjunct [1] 277:21
ADMINISTRATION [6] 1:2 7:16
61:20 118:13 132:20 172:11
adolescent [1] 301:4
adolescents [2] 299:15 301:8
adopt [1] 125:10
Adrian [1] 44:20
adult [11] 5:11,14 53:15 186:13,17
298:18 299:11 300:3,4,5 301:2
adults [11] 114:3 137:16 285:22
286:9,14 287:3,9,13 288:6 290:16,
22
advance [3] 76:2 282:5 298:13
advanced[16]
53:4 69:11 76:21113:19 143:11 153:12 167:5 187:
12 194:21 195:10 211:6 222:4
266:9,9 293:5 298:20
advances [2] 50:3 112:15
advancing [3] 60:1 66:19 205:3
advantage [2] 254:11 255:4
adverse [7] 76:19,20 82:1 151:18
210:17 211:1 279:19
adversely [1] 224:20
advice [3] 12:3,4 250:12
advise [2] 172:20 173:7
ADVISORY [10] 1:4 3:4 4:4 6:20 9:
18,20 52:4 106:11 172:15 186:18
Advocacy [2] 3:22 83:18
advocate [13] 77:19 78:3 187:17,20 188:12 189:21 217:20 234:10
236:19 248:1 276:20 280:13 281:
1
advocateB-we [1] 207:2
advocated [1] 216:18
advocates [1] 138:1
advocating [4] 228:7 278:5 279:5
305:2
AE [2] 252:4,8
AEs [5] 83:1 252:1 255:6,8 256:3
affect [7] 32:11 34:6 39:4 42:3 43:
3 46:17 143:5
affected [4] 88:8 91:5 98:21 188:3
affects [5] 43:2 60:5,6 267:7 286:1
affiliated [2] 186:13,17
affiliations [1] 173:20
afford [1] 78:21
African [20] 71:20 75:18 98:10,15
112:21 114:6 188:22 199:5,8 200:
16,22 201:8 302:20 304:8 306:10,
16 307:19 309:4 310:9,17
afternoon[2]
180:5 233:21age [16] 17:18 21:17 286:2,4 287:
19 289:17 291:7 292:5,8,10,11
293:19 298:19 300:13,17 301:11
aged [2] 108:21 301:4
agencies [1] 88:17
agency [17] 16:19 107:14 121:10
139:17 142:8 155:7 156:20 157:1,
3,8 170:3 171:3,9 210:14 243:15
255:21 311:15
agency=s [2] 8:6 185:17
agenda [2] 8:22 15:11
agent [39] 14:11,19 30:5 31:10 36:
14 100:15 124:12 129:21 130:2,
16,19,22 131:3,15,22 132:2,11,11,
13,20 133:2,12 140:14,19 158:22169:9,21 179:9 197:12 235:4 242:
14,16 248:2,6 252:12 253:9 256:
12,16 277:21
agent-to-agent [1] 36:10
agents [60] 14:22 19:22 29:22 38:
8 42:1 51:14,18,20 64:22 75:8 81:
13,13 94:17,20 97:7 100:13 101:3,
6 104:4 114:21 117:7 119:16 124:
8 125:8 131:6 133:7,21,22 140:2,
20,22 141:13 145:14 154:5 158:
12 159:19 160:13 161:12,19 179:
16 184:17 185:11 191:14 195:20
218:19 236:2 239:6 247:3 251:2
253:1 260:22 275:5,17,17 276:14,15 277:3 278:17 282:7,7
ages [1] 286:20
aging [3] 108:14 199:14 217:4
ago [9] 20:22 25:17 26:20 85:18
89:1 92:14 105:8 112:8 148:4
agonists [1] 12:10
agree [26] 113:21 194:2 203:15
205:14 216:9 220:11 223:18 237:
3,6,14,15,18 238:4 240:5 243:14
255:2 256:2 257:5 277:5 281:6,21
283:20 296:6 297:7 305:10 307:
15
agreed [3] 85:11 214:20 270:9
agreement [9] 115:17 116:12 122:
10 130:2 140:13 211:4 225:16244:2 311:16
ahead [11] 90:1,7 91:1 96:2,3,11
99:7 209:4 231:2 254:7 301:12
Ahold [1] 224:5
AIDS [7] 3:22 83:18 87:5 97:19 98:
4 186:13,17
aim [1] 200:21
akin [1] 235:6
Alan [1] 42:6
Albany [3] 5:15,16 10:2
Albrecht [8] 3:28 173:19,22 174:1
180:2 191:15 220:7 236:10
Albrecht=s [1] 197:17
albumins [1] 110:22
alcohol [4] 18:1 46:3 99:3 189:7algorithm [2] 20:4 166:21
algorithms [1] 19:21
allograft [1] 274:8
allow [10] 60:12 80:15 82:3 162:10
163:19 164:4,10 262:7 264:8 267:
21
allowing[1]
51:2allows [4] 56:9 81:6 164:8 182:16
almost [10] 11:2 35:9 74:7 199:3
275:15 276:6 277:3,11,18 279:1
alone [11] 11:10 100:13 101:3,6
153:7 233:13,14 286:7 289:6 292:
18 304:4
alpha [2] 11:9 72:15
alpha-2a [1] 42:1
alpha-2b [4] 41:3 42:2,5 71:2
alpha/beta [1] 59:11
already [23] 8:21 90:20 98:18,18
100:6 109:3,5 111:8 113:2 115:2
119:8 128:15 132:11 140:19 170:
19 190:9 237:18 258:8,11 262:19
280:18 287:6,7ALT [4] 53:16,21 75:1,19
Alter [41] 2:14 16:13,13 21:15 49:
21 142:18,19 146:15 150:9 151:
14 166:21 205:5,6 206:17,18 213:
11,12 215:3,10,12 216:19 245:12,
13 246:8 249:12,13 251:7 253:12,
13 254:2,12,18 303:16,17 304:7,
10 305:6,10 307:5 309:12,13
altered [3] 47:18,19 145:2
alternatives [1] 194:5
although [12] 47:9 71:1 72:3 84:8
135:18 167:16 218:9 239:22 266:
12 289:15 292:11 306:21
ALTs[1]
136:12Amany [1] 83:8
amazing [1] 50:2
amazingly [1] 280:6
American [5] 66:14 188:22 306:16
309:4 310:9
Americans [20] 66:10 71:20 75:18
98:10,15 112:21 114:7 199:5,8
200:16 201:1,9 216:21 302:20
304:8,11,19 306:10 307:19 310:
17
Amiles [1] 49:21
Among [16] 17:18 21:20 28:3 62:2
107:4 117:16 123:10 132:5 140:
13 166:14 199:1 210:1 235:15
276:15 310:17,18amongst [2] 98:4 99:5
amount [7] 31:7 91:7,12 92:22 93:
7 166:14 261:13
amounts [4] 33:5 67:19 69:5 70:
22
ample [1] 15:20
amplification [2] 25:11,12
amplify [1] 261:18
amplitude [1] 182:11
analogous [3] 131:5 242:11 282:4
analogs [3] 12:9 151:16 153:11
Sheet 2 accuracy - analogs
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 3/28
analogy [4] 22:10 125:9 163:2 239:
1
analyses [2] 153:4 213:9
analysis [19] 22:20,21 42:15 58:2
61:12 64:16 76:19 77:17 145:19
146:2 161:17 163:19 167:7 170:
11,11 268:11 275:7 277:22 289:8
analyzed [2] 71:18 195:9
analyzing [2] 67:11 180:21
ancestor [1] 20:8
ancillary[2]
152:12 168:8and/or [4] 13:10 81:15 131:11 170:
13
Andersen [32] 2:5 5:19,19 7:19
158:4 169:5,6 212:15,16 229:8,9
239:9,10 246:14,15 248:16,17
251:9,10 265:2,3,13 266:1 272:6,
7,19 303:2,3 305:1,7 308:5,6
Andy [1] 42:5
anemias [1] 81:1
Angeles [1] 86:7
animal [3] 96:7,9,17
Annals [1] 98:1
announcement [1] 6:14
Another [23] 33:16 103:9 115:12
122:9 128:4 131:2 152:6,7 162:21168:12 169:10 176:14 179:9 227:
2 235:4 237:20 255:14 282:18
283:1 284:4 289:12 303:14 310:
21
answer [28] 101:9 123:14 137:21
145:5,9 146:14,16 149:10,17 156:
9 157:11 159:5 167:16,19 171:3
198:5 200:7 208:1 218:11 220:6
225:14 244:10,15 248:7,10 264:
13 285:7 296:5
answers [5] 44:16 94:22 96:22 99:
7 198:21
antagonize [2] 57:15 60:22
Anthony[4]
3:30 186:12,15,16anti-HCV [1] 132:14
antibody [1] 26:5
anticipate [3] 154:4 183:5 278:15
anticipation [1] 307:18
antigen [1] 56:5
antigen-specific [1] 184:9
antihepatic [1] 282:8
antimicrobials [1] 277:12
antiretorviral [1] 260:2antiretroviral [6] 73:3 259:15 260:21 261:3 263:1 267:21
antiretrovirals [2] 260:16 264:2
antisense [1] 12:10
ANTIVIRAL [28] 1:4 3:4,10,25 4:3
6:6,10,19 29:22 51:14 59:3,19 89:21 133:13 159:14 160:5 161:1
163:4 169:21 181:8 183:7 184:17
185:10 186:3,5 282:4,5,22
antiviral-based [2] 89:18 159:17
Antivirals [4] 6:8 159:21 183:14
251:8
anybody [1] 158:11
Anyway [5] 148:10 166:11 213:19
267:1 278:4
Apelian [4] 3:29 180:3,4,7
apoptotic [1] 57:7
apparent [2] 117:15 269:20
apparently [1] 170:3
appear [5] 109:19 112:22 227:15
236:1 309:8
appearance [1] 6:17
appears [7] 19:4 24:12 35:22 46:5
103:13 132:7,13
applaud [1] 180:17
applicability [3] 7:8 66:13 100:20
applicable [2] 124:2 165:2
applicably[1]
145:21application [7] 13:8,9 215:18,19,
20,22 248:15
applications [1] 13:14
applied [1] 125:11
applies [1] 311:1
apply [7] 7:12,15 124:1 205:11
208:5 210:10 229:5
applying [1] 230:6
appreciate [3] 93:21 190:15 196:
11
appreciated [2] 156:16 185:19
approach [12] 88:7 95:3 134:6
154:18 162:22 170:2 177:20 209:
3 221:20 248:20 256:6 294:12
approachable [1] 209:14approaches [3] 185:18 216:22
264:15
approaching [1] 64:8
appropriate [20] 7:3 14:10 26:3
118:8 121:16 125:19 156:22 203:
13 207:5 209:17 213:17 239:15
245:7 248:20 265:15 276:17 278:
2 281:3 283:14 311:20
appropriately [1] 194:3
appropriations [1] 167:18
approvable [3] 132:16 248:4 257:
17
approval [94] 13:6 93:14,19 95:22
137:15 138:7 162:22 177:7,11,19,22 197:1,12,18,18 205:19 206:13,
16 208:9,10 209:22 211:19 212:8
215:21 216:4,12 217:21 218:21
224:14 225:15,19 226:6,11,11,13
227:17,21 228:9,12 230:15 233:9,
13 234:8 235:11 241:22 243:9
244:3,20 245:1,14 246:6 247:22
249:6,7 250:13 251:16 253:11,21
257:10,13,13 258:19 260:10,13
263:16 264:9,11,21 268:8 269:2
270:21 271:1 281:4 282:1 284:13,
16,17 285:19 288:9,18,22 294:2,6,
14 295:18 296:14,20 297:2,3,5
301:17 305:13,14 311:7
approvals [2] 207:16 311:5approve [2] 250:7 283:17
approved [23] 11:10 13:16 86:5
91:11 138:17 205:16,20,22 230:
10 235:10 239:3 262:22 269:10
287:15 288:1,5 289:3,17,21 290:2
295:8 296:2 299:16
approving [1] 285:8
Approximately [11] 10:17,19,21
18:16 48:3 79:3 201:2 286:1,3,6
308:13
approximation [1] 164:16
Aprior [1] 270:15
arbitrarily [2] 67:3 69:5
arbitrary [2] 41:11 166:8
area [18] 16:21 98:11 111:9,10 177:
1 187:6 192:12 196:13 250:11
252:5,8 271:18 274:9 280:17,22
282:3 285:11 301:20
areas [11] 18:22 44:14 47:16 68:1
97:21 107:5 108:2 130:5 135:20
204:12 279:1
aren=t[6]
135:21,22 195:12 207:13 226:9 307:8
arena [4] 187:6 224:7,8 280:21
argue [3] 76:11 262:12 267:9
argued [1] 89:21
arguing [3] 296:21,22 297:1
argument [8] 78:16 89:19 90:4
227:3 235:19 261:9 291:2 298:13
arise [2] 210:12,17
arising [1] 19:12
arm [5] 86:10 117:18 143:6,6 278:
21
armamentarium [1] 184:14
arms [7] 7:3 59:6 131:22 155:10,
21 266:4 278:21
around [11] 33:17 41:21 42:17 86:6 87:8 133:3 144:15 187:6 211:14
273:3 277:22
arrive [2] 244:15 246:5
arsenicals [2] 82:22 83:1
article [2] 98:1 151:5
articles [1] 135:17
articulated [3] 119:4 132:10 135:7
articulation [1] 219:15
ascertain [1] 278:10
ascites [2] 45:13 110:20
Asia [1] 20:18
Asians [1] 304:21
aside [1] 297:8
aspect[1]
32:21aspects [2] 69:1 154:20
aspiration [1] 67:18
assay [2] 34:22 41:18
assays [5] 25:8 26:8 27:2 97:8
193:1
assembly [1] 108:10
assess [3] 67:2 161:11 233:5
assessed [1] 166:1
assessing [1] 19:21
assist [1] 107:21
associated [8] 18:3 21:9 25:21 30:
15 47:19 49:17 51:4 151:7
assume [3] 43:7 161:4 300:1
assumes [4] 43:9,13,16,19
assuming [7] 146:22 191:12 206:19 228:9 252:21 297:20 298:2
assumption [4] 207:1 224:1,2
242:13
assured [1] 118:14
asterisk [1] 120:8
at-risk [1] 167:5
attack [1] 56:12
attempt [1] 57:19
attempted [1] 127:16
attempts [2] 127:21 275:1
attendance [1] 173:5
attendant [2] 11:19 109:12
attendees [1] 87:7
attention [9] 26:2 58:14 85:9 108:
3 142:4 152:15 186:9 202:4 217:
15
attract [1] 204:9
attributable [3] 22:14 210:11,12
AUC [1] 164:3
augment [3] 56:11 62:20,22
augmentation [1] 62:4
augmenting[1]
58:22author [1] 40:15
authors [1] 128:8
availabilities [1] 78:5
availability [1] 280:8
available [23] 7:22 8:2 27:2 41:1
53:17 54:8 69:19 148:6 165:16
179:2 205:22 212:18 214:17,19
218:21 232:16 244:22 260:12 262:
21 264:10,19 289:5 294:11
average [4] 88:3 113:19 114:20
194:13
aviremic [4] 274:6 279:7 282:15,
16
avoid [5] 103:20 120:5 190:7 212:
18 274:8avoidance [1] 126:17
Award [1] 9:20
aware [8] 83:3 117:9 168:21 169:
14 182:20 190:10,14 291:15
away [5] 122:12 133:1 163:21 189:
16 255:21
Awell [1] 249:21Awouldn=t [1] 125:14
axis [1] 71:22
Ayou=re [1] 136:6
BB-we [1] 270:7
B/hepatitis [1] 112:14
back [20] 4:15 28:5 38:16 41:17
106:9 132:1 157:17 165:19 166:
10,22 169:6 173:14,16 176:3 207:
19 208:18 226:19 241:4 254:19
267:14
backbone [6] 159:9 175:6 176:8
179:17 209:11 290:15
background [2] 17:1 84:11
bad [6] 47:4 104:19 108:13 258:7
272:3 279:19
balance [5] 55:20 56:18 213:7 280:
7 299:3
bar [2] 242:6 289:2
Baraclude [1] 180:15
barest [1] 261:12barrage [1] 57:17
barriers [3] 200:19 309:2,8
base [1] 40:2
based [34] 19:20 22:18 23:11,12,
21 25:14 26:6 39:13 41:9,11 48:
13 49:11 66:7 69:3,8 75:1,2 81:21
109:15 122:11,17 123:21 151:8
159:19 165:8 166:12 168:13 169:
1 180:8 187:5 233:13 236:15 250:
18 292:17
baseline [3] 40:18 113:10 269:13
bases [1] 72:14
Sheet 3 analogy - bases
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 4/28
basic [3] 29:12 225:21 263:14
basically [15] 40:16 106:20 113:6
116:13 125:14 128:18 134:15 137:
3 138:7 139:2 154:15 187:6 189:
13 212:16 272:20
basis [15] 12:15 66:19 71:18 75:20
136:18 141:22 150:19 156:5 180:
20 201:19 246:11 277:13 279:1
308:15 311:22
bat [1] 212:7
bathroom[1]
42:22Baylor [1] 6:2
bearing [1] 117:3
became [1] 92:14
become [11] 27:20 40:2 56:3,6 87:
11 120:9 170:14 176:3 181:17
187:10,12
becomes [5] 26:8 121:4 129:3
187:12 303:5
becoming [1] 167:11
began [3] 23:16 49:22 148:4
begin [13] 9:9,16 29:9 30:22 33:3
51:8 142:7 164:16 197:14 232:22
233:5 292:6 309:14
beginning [4] 163:12 172:19 173:
6,10beginnings [1] 47:15
begs [1] 266:19
behalf [2] 8:15 198:16
behave [4] 42:2 117:4,8 298:18
behind [1] 4:16
believe [30] 87:15 108:6 121:7 126:
5 129:3 130:10 145:12,13 150:14
151:19 170:10 172:12 175:9 176:
7 177:6 184:2,11,19 200:16 224:
16 229:1 234:6 255:15 264:16
280:17 285:6 304:17 307:1,1,3
believes [1] 172:16
Bellevue [1] 84:17
below[2]
34:21 165:10benefactors [1] 109:21
beneficial [2] 159:1 169:11
benefit [19] 124:19 128:4 134:5
142:2 146:5,6 153:21 166:17 168:
21 169:4 185:3 192:3,21 204:19
205:4 250:2 269:20 284:9,11
benefits [1] 184:5
best [6] 81:4 119:7 123:16 178:20
242:1 286:11
bestow [1] 9:19
bet [1] 299:6
bets [1] 121:22
better [22] 42:6,12 74:14 95:10
112:17 148:21 151:11 164:8 175:
4 179:5 181:1 190:1 217:9 219:14222:16 237:11 241:20 250:5 261:
6 290:17,22 298:21
between [25] 17:18 34:3 37:21 38:
7 47:16 49:5 52:8 68:16 101:21
117:5 141:11 184:21 199:11 204:
14 207:12 211:15 213:2 237:7
245:20 250:19 251:22 266:3 280:
8 294:6 312:14
beyond [3] 95:4 116:3 165:12
bias [1] 205:18
Biceglie [1] 44:20
big [7] 17:12 38:20 42:11 191:16
269:5 296:18 309:3
bigger [1] 297:2
bilirubins [1] 110:22
Bill [3] 6:5 13:1 15:17
billion [3] 49:5,6 88:16
biochemical [5] 15:5 99:18 125:6,
18 140:2
biochemistry [1] 54:7
biologic [1] 308:2
biologically[3]
144:9 297:18 298:18
biology [5] 265:22 297:21 298:3
299:8 300:21
biomarkers [1] 168:8
biopsies [6] 46:22 61:11 67:15 68:
9,16 281:10
biopsy [14] 47:1,1 54:5,8 66:17 67:
8,18,21 68:3 75:2,3 101:13,21
293:1
biphasic [2] 58:1 183:10
Birnkrant [28] 2:22 3:9 6:9,9 9:10,
15 10:6 16:18 21:11 22:4 108:13
157:14 211:3,4 214:16 215:16
216:11 248:12 250:9,11 271:4,5
288:12,13 292:4,5 300:11,12bit [23] 22:17 28:12 47:2 66:5 68:
21 84:11 85:18 98:9 100:4 112:11
132:8 158:18 163:11 207:20 208:
2 210:15,22 216:5 242:12 262:18
294:7,8 300:18
bits [1] 135:19
black [3] 188:22 307:13 311:9
blacks [4] 21:21 304:7,14 307:4
blamed [1] 94:21
Blatt [1] 66:7
bleeding [3] 45:14 110:20 167:9
blip [2] 35:18,22
blocked [1] 43:1
blocking[2]
30:20 31:4blocks [1] 30:21
blood [11] 23:18 47:18,19 53:17
57:1 160:21 183:16,20 195:14
260:6,7
bloodstream [1] 27:16
blue [3] 47:4 52:19 69:3
blunted [1] 55:1
board [3] 100:18 106:22 186:19
Bob [1] 16:11
body [2] 24:19 302:22
bolus [2] 21:17 48:14
bone [1] 127:13
boosting [1] 266:17
born [1] 24:2
Boston [2] 5:21 16:10both [45] 13:8 15:21 17:8 18:12 21:
9 32:5 36:22 41:20 48:12 50:22
55:10 57:8 71:9 72:5 87:17 111:
22 119:12 122:21 123:1,13 125:
16 155:13 156:3 172:12 177:8
188:13 191:6 208:14 233:14,21
234:7,10,19 237:4 238:4 243:20
244:12 261:18,22 262:13 266:8
267:19 268:21 281:18 302:17
bottom [1] 75:9
Boulder [1] 180:9
box [1] 265:4
Boy [1] 251:17
Branch [2] 16:15 20:6
branches [2] 20:10,12
brave [2] 119:19 197:16
breadth [1] 137:20
break [7] 83:16 89:9 106:4 142:6,
15 257:22 258:6
breaks [1] 4:13
breakthrough [1] 65:14
Brian[2]
22:16 307:6bridges [1] 47:15
brief [4] 16:21 106:5 258:4 285:13
briefly [7] 15:10 18:7 29:12 51:8
74:18 312:6,7
bring [12] 30:5 123:2 138:20 166:
10 213:1 222:7 229:12 247:14
248:17 260:20 261:10 310:22
bringing [1] 266:2
brings [1] 81:3
broad [3] 177:4 182:5 207:16
broaden [1] 225:3
broader [2] 7:8 259:19
broadly [1] 234:16
brought [7] 108:3 118:19 125:9
142:8 148:3 282:5 303:3bugaboo [1] 248:18
Building [1] 8:7
bulk [2] 107:2,12
bump [3] 25:20 26:12 169:11
burden [4] 10:15 24:13 217:6 230:
1
burst [1] 43:12
bursts [1] 57:13
button [1] 4:7
CC-specific [1] 282:7
calcineurin [1] 277:9
calculates [1] 29:17
calculations [1] 238:11
California [3] 5:12 190:18 191:3
Call [12] 3:2 4:2 19:12,17 37:15 47:
6,20 58:14 173:17 179:11 197:15
237:22
called [6] 4:4 31:18 32:8,19 116:5
152:7
came [7] 23:4 102:16 142:15 143:
16 148:6,10 190:19
camera [1] 295:7
camp [2] 113:7,16
camps [1] 113:7
can=t [23] 42:20 43:22 94:10 100:
10 101:8 124:18 128:12 143:14
149:16 189:19 217:13 240:17 241:12,18 244:15 246:3,3 260:19 261:
1 288:20 289:4,4 309:18
cancel [1] 27:4cancer [4] 149:16 180:10 195:6
222:22
candidacy [1] 74:18
candidate [1] 59:1
candidates [5] 75:7 137:15 138:7
151:12 266:16
cannot [3] 94:11 154:14 307:1
capabilities [1] 38:10
capable [3] 81:5 82:4 167:15
capacities [1] 277:8
capacity [13] 28:1 56:12 57:14 60:
18 61:9,17 62:4,9,12,21 63:6 145:
2 170:12
carcinoma [16] 21:10 45:16 48:6,
12 54:16 80:5 82:11 108:16 124:
21 154:2 166:19 167:13 168:7,10,
21 217:6
cardiovascular [1] 188:10
care [80] 11:12,14,17 13:21 14:11
49:6 51:13 59:6 70:5 73:14 75:976:3 77:8 82:5 85:19 86:2 88:15,
19 89:3,3 94:13 103:3,8 109:7
111:17 113:3 118:11 129:22 130:
20 131:4,11,21 132:2,16 134:7,8,
18 139:4 140:15,21 143:3,7,10,15
147:7 148:22 149:3,21 156:18
157:2 158:11 166:16 169:10 189:
15 207:22 209:11,13 217:17 240:
19 242:2 252:11,20 253:5 262:7
264:17 269:7 272:21 275:9,12,13,
16 276:19 278:3 287:8,12,12,13
289:5 290:4 292:22
careful [8] 124:1 153:4 170:11 210:22 242:4 259:7 295:15 296:19
carefully [5] 189:21 238:14 267:13278:14 307:22
carinomas [1] 136:4
carry [2] 128:4 188:2
cartoon [1] 28:8
case [13] 24:13 34:18 91:6 92:7 97:
21 98:2,5 181:12,18 198:11 208:1
215:5 297:9
cases [7] 31:21 49:15 123:1 125:3
154:16 163:4 272:1
catch [1] 126:7
categorically [2] 283:13,17
categories [13] 25:1 66:3 69:16
206:5 215:17 218:9 219:14 227:1
235:16 283:18 294:1 295:19 296:16
category [7] 134:17 154:21 181:8
206:7 218:19 273:7 296:10
Caucasian [1] 72:6
Caucasians [2] 71:20 304:6
cause [9] 27:19 52:21 59:7 97:18,
22 98:3 99:2 187:10 230:8
caused [1] 261:5
causes [3] 17:15 57:7 132:22
causing [3] 44:3 73:4 127:14
cautious [1] 141:12
caveat [2] 205:21 287:10
caveats [1] 67:7
CD4 [5] 55:11,20 56:1,21 60:8
CD8 [1] 55:12CDC [5] 21:14 22:7 23:6,11 24:4
cell [10] 43:16 56:2,4,5,13,18 57:859:8,20 82:5
cells [21] 30:9,11 32:1 52:10 53:2
56:7,15 57:3,18 58:9,17 60:10,11,
14 68:8,8 82:4 135:20 162:16 184:
7 246:20
cellular [6] 181:20 182:4,10,15,22
185:2
CENTER [8] 1:3 3:19 5:8 6:18 10:
2 21:22 210:6 281:16
Sheet 4 basic - CENTER
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 5/28
centers [8] 32:18 129:1 185:17
225:6 267:18 272:22 274:4 281:
21
certain [28] 11:18 13:17 62:14 87:
20 88:9 90:16,16 91:9,12,12 92:2
93:1,2 97:20,21 120:9 125:12 141:
2 165:10 181:2 204:8 210:20 225:
6 226:22 238:21 239:2 245:8 302:
11
certainly [36] 43:15 52:1 81:13 83:
13 99:4,16 117:8 121:14 135:8140:8 145:8 147:9 151:20 152:19
155:19 175:9 179:17,21 193:20
196:14 198:14 201:14 203:11 207:
13 209:19 210:19 216:17 277:3
280:13 285:15 291:10 292:10 293:
1 295:3 311:5,7
Chair [2] 2:2 3:4
Chairman [1] 173:22
challenge [6] 95:9,18 138:15 224:
19 236:9,14
challenges [1] 94:18
challenging [1] 97:2
Chalmers [1] 297:8
chance [4] 45:9 65:21 145:1 157:9
chances [1] 119:9change [18] 29:16 30:6 31:22 46:7
57:8 67:6 85:20,22 89:7,11 122:2
125:5 136:14 140:6 157:4 218:3
233:19 277:13
changed [4] 95:4 170:13 206:18
255:18
changes [10] 19:15 31:4 33:7 47:
19 67:4 68:17 113:10,20 140:10
277:10
changing [4] 63:5,6 234:13,14
characteristic [2] 56:21 182:5
characteristics [4] 18:7 109:16
130:19 180:22
characterizations[1]
96:1characterize [6] 98:16 102:9,20
230:2,13 261:7
characterized [10] 22:22 58:7 66:
22 177:5,8 191:19 193:17,20 219:
10 236:12
characterizes [1] 38:6
characterizing [1] 102:3
charge [1] 152:15
charges [1] 117:14
chief [1] 180:7
Child [4] 128:15 129:1,7 287:2
child=s [1] 293:14
children [24] 24:1 45:3 154:12 286:
2,3,6,7,9,12 287:15,18 288:10 290:
17 291:3,5,7,21 292:17,21 293:9294:19 295:1,7,8
choices [3] 251:22 281:17 298:12
cholestatic [1] 284:9
cholesterol [1] 104:13choose [4] 173:8 207:8,8 269:14
chosen [1] 42:13
Chronic [38] 3:15 6:22 10:20 17:
16,21 18:2 21:7 22:12 23:19 25:
19 26:14 27:5 28:16 50:13 51:1
53:14 76:22 80:20 82:2 106:19
108:22 109:3 110:6,14 118:7 129:
4,6 134:2 152:11 174:6,10 180:11,
12,15 183:3 186:8 306:16,18
chronically [3] 11:2 181:17 182:9
chronicity [2] 45:5,6
Chung [42] 2:16 7:18 16:8,8 89:19
151:4 158:1,2 159:7 163:2 209:18,
19 220:18 233:19,20 235:12,13
236:19 242:8,9 243:19 247:1,2,21
248:6 249:4 250:15,16 251:17
252:18 253:4,22 254:9 257:4,5
261:17,18 272:15 281:5,6 307:14,15
Chung=s [1] 211:5
chute [1] 102:17
Cicely [4] 2:3 3:6 5:9 6:11
Cincinnati [1] 3:19
circles [1] 47:3
circumstance [3] 162:8,14 275:
19
circumstances [1] 52:14
cirrhosis [65] 21:10 38:22 39:2 45:
6,11 46:14,18 47:6,6,8,10,12,17
48:7 54:2,11,20 55:4 66:22 69:11,
22 74:5 76:16 88:4 108:17 110:16,
17,17,18 111:2,3 114:1 124:20
147:17,22 148:20,21 194:20 195:4,8 197:9,22 198:4 201:20,20 203:
9,11,18 208:4 209:10,13,15 210:6
212:5 213:14 216:10 218:20 225:
17 232:12,14 258:11 263:22 273:
8,9 274:17
cirrhotic [12] 45:11 48:1 54:15 93:
4 136:16 145:22 152:3 153:19
168:19 209:20,21 270:9
cirrhotics [10] 78:20 80:17 88:10
137:18 150:10 153:12 208:12 222:
3 224:11 226:2
cited [1] 125:20
cities [4] 87:4,5,7 97:20
City[4]
5:5 87:3,10 98:4claimed [1] 25:6
clarification [5] 142:14 155:7 157:
11 271:3 272:15
clarifications [1] 142:16
clarify [1] 226:20
clarifying [2] 235:13 236:18
clarity [2] 155:19 211:14
class [6] 152:4 184:22 268:18 304:
3 309:10 310:1
classes [2] 185:6 276:15
classification [2] 18:9 19:16
clear [31] 20:7 22:12 33:18,22 38:3
39:11,12 40:20 53:3 55:16 56:13,
22 57:19 58:17 68:8 72:3 101:12
109:17 180:19 182:2,6,17 184:20185:5 244:15 254:10 270:5,14
294:5 297:21 301:1
clear-cut [1] 237:8
clearance [54] 28:13,14 29:15 30:
8,12,15 32:1,3,5,6,7,8,10 34:6,21
37:10,14,21 40:11 43:8,8,12,22
51:9 53:11 57:5,10,17 58:8,13 64:
1 81:1 82:6 120:5,6,12 121:3 122:
21 124:9 144:1 161:21 163:1,5,5,
9 169:3 183:19,22 184:1,16 253:3
286:17 299:15 301:1
cleared [8] 27:17 30:12 35:1,9 44:
2 162:16 242:19 293:13
clearing [2] 165:17 184:7
Clearly [33] 14:3 37:20 42:14 46:
16 73:22 74:20 80:6 95:16,22 109:
15 111:3 117:18 144:7 160:16
163:5 169:16 181:3,13,16 199:13
201:18 204:13 212:20 214:19 232:
6 239:5 253:5 258:12 259:1 263:2
265:18 274:20 277:17
clinic[2]
182:19 212:12Clinical [55] 3:14 5:22 6:20 11:14
12:17,21 13:1 21:1 37:4 39:17 41:
8,14 47:7 50:8,12 51:17,19,20 52:
3 55:5 60:2 65:16 75:16 80:15 81:
12 96:11 100:8,9 106:18 130:3
135:3 137:4 139:1 157:16 166:9
174:2 176:11 179:15 186:14,17
190:21 191:4 192:12 194:12 242:
4 245:11 250:4 253:19 266:10
278:3 281:20 282:19 300:13 309:
2 311:3
clinically [3] 47:10 140:5,10
clinician [1] 265:14
clinicians [1] 166:11
clinics [1] 88:17clock [3] 45:12 54:12 121:8
close [4] 19:21 20:5 33:21 302:13
closely [1] 85:6
closer [2] 33:11 87:9
clotting [2] 23:14,16
clue [1] 212:12
cluster [1] 69:18
Cmax [1] 277:8
Cmin [1] 164:3
co-chair [1] 186:19
co-factors [1] 114:1
co-infected [15] 189:3,5 231:21
240:12,15 260:21 261:15 262:8,
10 266:8 267:5 268:10 271:13272:5 310:7
co-infection [6] 221:16 258:18
262:1,2,13 271:21
co-infections [2] 187:16,17
co-morbidities [4] 13:12 196:2
258:3,17
co-morbidity [1] 188:5
co-pilot [1] 167:9
co-primary [1] 123:13
cocaine [1] 24:17
cocktail [1] 81:22
cohort [4] 73:6 111:15 153:22 217:
4
cohorts [3] 104:8,10 105:6
coincide [1] 58:11coinfected [21] 34:13 35:6 36:5,
18 37:2,11 38:1 46:13 72:22 73:
10 76:14 78:11 92:1,4 93:3 98:6
99:5,20 115:6 136:17 137:22
coinfection [23] 46:4 72:19 84:18,
20 87:13,16,19 88:15,21 89:2,6,8,
12 97:15 98:20 99:13 100:1 104:9,
12,17 112:8,14 114:2
coinfectionB-I [1] 104:15coli [1] 251:4collaborating [1] 105:11
collaboration [1] 105:9
collagen [2] 53:3 61:19
collagenase [2] 61:17 68:14
colleagues [4] 67:16 70:7 186:21
312:12
collect [3] 34:15,16 215:2
collected [1] 212:9
collecting [1] 97:11
College [3] 5:2,15 6:3
color [1] 306:4
Colorado[1]
180:9combination [11] 11:11,12,15 133:
11 162:19 185:11 240:3,3 244:22
249:15 252:22
combinations [4] 11:16 160:13
185:16 254:21
combine [2] 94:19 213:4
combined [6] 153:7 161:4 179:20
246:22 256:22 264:1
combines [1] 17:22
combining [2] 94:16 97:7
come [24] 9:22 16:5 17:1 26:2 42:
22 85:15,17 93:6 94:17 95:21 100:
2 105:19 122:4 155:22 162:18
165:19 169:21 203:7 208:18 219:
15 226:19 256:4 287:5 296:15comes [3] 17:17 37:6 283:15
comfortable [2] 122:16 226:21
coming [4] 176:3 230:18 273:9
285:21
commend [1] 190:12
comment [16] 9:6 114:6 145:18
155:7,14 167:21 205:11 216:7
218:7 219:17 234:20 250:10 251:
12 284:5 292:5 312:5
commentary [4] 172:2,8 196:18
232:10
commented [3] 119:18 127:18
230:9
commenting[1]
12:6comments [13] 153:2 158:3 191:1
223:21 233:16 243:22 244:1 268:
1,7 273:12 283:2 288:2 292:3
commit [1] 221:15
commitment [5] 124:7 220:8 221:
8 230:20 232:2
commitments [3] 212:14 230:11
285:4
committed [1] 177:21
COMMITTEE [52] 1:4 3:4 4:4,6,18
6:20 7:6,10 8:11,17 9:18,20 64:13
106:11 117:14 121:15 138:20 140:
9 142:11 171:10 172:15,21 173:7
178:8,12 179:4 180:17 184:21
185:5,13,21 186:6,9,20 187:4 189:6 190:9 192:10 196:20 197:4 232:
8 243:8 244:1,16 246:9 249:10
257:11 270:2 273:12 283:3 288:3
309:6
committee-wide [1] 142:17
committee=s [5] 7:1 175:21 176:
15 181:7 232:11
committees [1] 185:5
common [8] 10:22 20:8,18 75:20
109:4 187:10 247:20 268:14
commonly [4] 21:19 44:21 120:19
Sheet 5 centers - commonly
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 6/28
260:17
communications [2] 4:10,12
communities [2] 98:22,22
Community [23] 3:20 15:17 44:21
75:16 80:11 83:19,20 84:16 86:6,
8,21 87:6 95:7 102:11 105:17 112:
11 185:20 186:18 187:5 234:12
274:20 275:22 312:13
community-based [1] 88:18
companies [19] 44:10 85:3,11 90:
12 92:8,20 93:11 96:16 97:3 105:9,16 176:22 177:21 182:21 257:1
269:18 289:2 296:1 300:9
company [6] 8:18 172:22 180:8
214:20,22 246:4
company=s [2] 173:3 177:15
comparability [1] 79:9
comparator [4] 36:10 117:18 131:
22 139:5
compare [2] 121:13 200:22
compared [14] 55:14 59:22 69:4
73:18 117:17 132:15 134:8 163:7
183:7 252:19 265:19 286:8,14
298:2
comparison [4] 36:11,16 68:4
152:8comparisons [2] 38:7 165:22
compartment [2] 43:20 160:7
compartmentalization [1] 144:3
compassionate [2] 222:18 223:3
compelling [3] 87:19,20 197:20
compensated [30] 13:9 54:22
110:13,16,16,17 111:7 113:22
118:6 120:2 126:6 137:17 147:18,
22 197:8 202:20 203:5,9,17 208:
11 209:13,20 213:4 216:9 217:22
224:11 228:4 231:17 232:12 285:
10
competition [1] 132:15
complementary[2]
133:22 185:8complete [6] 32:15 149:17 150:22
167:7 204:15 239:12
completed [4] 211:15,18 243:10
284:1
completely [11] 62:16 78:17 122:5
151:15 223:18 225:18 228:17 231:
3 237:6 286:18 297:7
completing [1] 216:2
completion [3] 159:13 160:8 270:
12
complex [7] 10:9 16:21 31:1,15
164:18 166:5 186:7
complexity [3] 171:2 181:4 281:
16
compliance [7] 65:3,14 116:4,7253:15 310:15,17
compliant [1] 70:22
complicated [2] 203:3 221:4
complication [1] 167:8
complications [6] 49:11 88:4 108:
22 126:18 187:12 206:8
comply [1] 249:19
component [1] 60:7
components [1] 66:11
composite [1] 129:13
compound [1] 210:12
compounded [1] 246:11
comprised [1] 66:11
compromise [1] 216:18
compromises [1] 156:2
concentrate [1] 175:11
concept [7] 27:15 38:16 63:10
114:20 161:14 194:5,6
conceptualize [1] 208:22
concern [15] 103:12,16,18 118:18
121:11 130:9 135:4,7 210:16,20
228:20 234:12 259:4 277:15 290:10
concerned [8] 130:12 132:5 178:3
188:21 190:5 206:22 230:22 235:
22
concerning [2] 14:13 64:21
concerns [16] 82:17 134:20 135:8
181:9 189:11 211:7 232:17 244:4,
7,14,19 259:17 260:1 292:9 308:3
311:1
concludes [2] 142:3 196:17
concluding [2] 108:4 137:14
conclusion [2] 23:6 230:19
concomitant [2] 259:11,20
concur [1] 118:12
Concurrent [1] 134:11concurrently [1] 225:9
condensing [1] 64:14
condition [1] 145:11
conduct [2] 138:22 191:4
conducted [2] 157:16 267:18
conducting [1] 243:20
confer [1] 166:17
conference [2] 86:16 150:5
conferences [1] 86:18
confidence [6] 135:15 141:9,10
162:8 166:7 216:14
confident [2] 122:5 191:8
confine [2] 111:20 247:6
confined[2]
91:14 117:6confirm [2] 116:8 121:22
confirmation [1] 25:9
Confirmed [1] 24:7
Conflict [5] 3:5 6:12,13,15 9:8
conflicts [5] 7:14 8:9,11 173:20
191:9
confusion [1] 120:5
congruity [2] 107:4 130:6
connection [1] 173:4
consensus [10] 107:20 110:3 118:
7 131:18 143:21 226:15 232:11
246:8 273:4 275:21
consent [1] 213:17
consequence [1] 144:10
consequences [3] 110:19 205:1242:17
Consequently [3] 64:19 146:7
289:22
consider [28] 68:2 88:7 90:22 91:
3 93:8,13 95:2 96:6 99:6,9 100:10
101:3 103:12 129:7 158:5 170:7
178:12 183:13 187:4 188:13 192:
10 195:3 229:2 246:5 253:20 280:
14 294:2 308:18
considerable [2] 40:5 109:12
consideration [11] 70:1 78:3 81:3,
8 83:6 101:11 165:4 188:16 233:
15 276:2,13
considerations [2] 78:13 246:1
considered [12] 40:21 76:6 80:13
121:2 125:7,12,19 133:18 134:1
138:19 189:12 257:17
considering [4] 91:4 98:14 100:
19 110:7
consistent [1] 12:4
consolidated [1] 63:20
consortium[2]
105:8,12constant [8] 28:2 30:14,15 43:8,9,
17 57:17,18
constitute [1] 257:13
constituted [1] 115:18
constitutes [2] 176:5 245:1
constrained [1] 225:3
constructive [1] 180:18
CONSULTANT [1] 2:19
CONSULTANTS [2] 2:13 309:19
consumed [1] 276:9
Consumer [2] 2:9 16:11
contact [1] 27:18
contacted [2] 106:19 198:10
contain [3] 13:9 67:12 89:5
contend [1] 58:17contended [1] 277:7
content [1] 230:2
context [10] 164:7 172:16 209:12
256:13 263:22 264:2 269:9 294:
21,22 295:2
continue [13] 40:4 66:1 68:6 131:
3 137:3 157:7 159:12 188:18 189:
18 190:8,14 221:1 296:12
continuing [3] 45:8 112:10 167:1
continuous [1] 308:15
contra [2] 56:16,18
contradiction [1] 187:14
contraindicated [3] 127:12 134:
20 140:21contraindication [1] 79:8
contraindications [1] 75:5
contrast [2] 71:11 184:6
contravene [1] 63:2
contribute [1] 243:17
contributor [1] 24:12
control [11] 7:3 14:1 79:16 118:8119:3,20 134:10 143:6 144:4 150:
2,3
controlled [4] 78:17 79:6 105:1
218:13
controls [7] 12:20 13:20,21 42:14
118:5 139:4 192:15
controversial [2] 32:21 110:11
controversies [1] 51:21controversy [3] 58:10 100:9 244:
4
conundrum [2] 55:14 288:21
conundrums [1] 82:21
conversation [2] 187:5 264:14
Conversion [1] 68:13
convert [1] 182:14
convinced [1] 297:14
copies [2] 8:4 120:21
core [1] 18:19
corner [2] 110:5 246:20
Corporation [1] 174:3
correct [8] 124:7 155:14,17 156:5
162:20 220:10 245:3 270:6
correction [1] 19:9
correlations [1] 101:21
correspondingly [1] 243:4
cost [4] 11:20 49:4 81:17 217:7
costs [5] 48:18 49:6,6,16,17
couldn=t [1] 213:15
counseling [1] 24:14
counterbalancing[1]
90:10counterpoint [1] 151:4
country [14] 34:11 86:6 87:2,9 109:
5 199:4 202:5 204:4,8,12 306:9,
15,18 309:12
county [1] 194:19
couple [12] 48:4 85:3,10 89:19 90:
10 103:9 176:22 190:22 191:10
192:10 287:21 290:9
course [22] 25:18 39:12 59:9 76:
22 115:8 116:14 130:22 149:7
150:22 160:2 168:7 183:12,18
192:6 201:11,13 210:2 221:10
227:2 237:17 252:12 282:17
cover [4] 84:4 120:4 202:17 266:
22coverage [5] 86:17 182:5,12 234:
13,13
crafty [1] 60:21
create [3] 39:17 101:6 210:22
created [3] 39:15 41:11 178:5
creates [3] 37:20 38:10 88:6
Crippen [1] 151:6
criteria [8] 26:17 138:18 150:18
175:13 176:20 189:3 269:1 279:
13
critical [3] 50:5 226:9 264:9
criticize [1] 95:12
crop [1] 257:20
cross-inhibit[1]
56:15cross-resistance [4] 96:1 102:10,
13,21
crossover [1] 118:13
crucial [3] 51:13 94:6 299:13crushable [1] 291:8
crushed [1] 291:9
crystalize [1] 223:22
CTP [1] 140:7
CTPA [1] 152:4
cure [6] 37:21 50:22 84:18 91:18
99:15 101:7
cured [6] 51:3 84:20 100:11 104:
21 176:4 231:7
curiosity [1] 117:2
current [19] 9:4 43:22 89:3 109:7113:14 143:2,10,15 147:6 156:17
157:2 160:22 166:16 184:14 189:
14,18 207:13 290:13 312:10
Currently [14] 11:9 35:20 65:2 79:
3 82:20 122:10,16 123:21 138:17
186:20 217:12 247:3 291:16,17
curve [6] 32:18 36:11,22 37:1 169:
17 183:11
cutoff [1] 166:9
cutoffs [1] 41:12
cutting [1] 96:18
Sheet 6 commonly - cutting
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 7/28
cyclosporin [1] 12:9
CYP [1] 230:5
cytochrome [4] 227:15 259:6 261:
20 268:16
cytokine [5] 56:3,17 57:8 63:5 170:
17
cytokines [4] 53:1 56:10,14 63:3
cytopathic [1] 52:15
cytoplasmic [1] 144:10
cytotoxic [4] 55:12 57:7,9,15
Ddaily [6] 58:3 135:4 163:15 164:6,
12,15
damage [1] 110:9
danger [1] 264:19
dangerous [6] 208:3 209:1,5 212:
20 213:18 219:6
dark [1] 104:3
data [108] 13:9,13,15 17:15 21:14
23:3 28:17 29:6 33:17 34:9,10 39:
16,19 40:1 41:1,2 43:3 64:14 66:7
68:19 70:16 71:1,13 74:10 77:16
80:15 90:16 91:8,8,12,19 93:1,7
96:2,3,17 97:11 98:6 136:19 138:
2 144:12 146:19,21 149:2 154:15164:6 167:3,6 168:13 169:8 176:6,
10,12 177:12 182:13 205:22 206:
3,5,6 208:11 211:16 212:9,11,17
215:2 217:3 218:12,20 225:22
226:22 227:1,5,10,11,12,14,16,17,
18 229:4,10,17 230:5 234:6 243:
10 246:21 260:3,10 261:13,14
262:20 263:3,6,9,13,18,20 264:1,
10 267:2 271:6,20 288:17 292:1
294:1 305:12,14,19
dataB-we [1] 271:6
database [2] 74:11 146:2
databases [3] 97:8,12 105:20
date [4] 144:12 169:14 257:2 291:
13
David [2] 3:29 180:7
Davis [1] 49:11
Davis= [1] 41:2
day [6] 10:10 19:6 197:13 258:7
287:19 312:4
days [15] 33:9,21 34:2,4,15,18,22
35:1 36:13 38:17 58:16 92:14 133:
14 191:11 282:15
dead [1] 216:21
deal [11] 42:18 95:10 175:2 188:7189:4 192:7,9 222:21 231:14 235:
3 307:10
dealing [9] 49:7 134:14 155:1 205:
7 230:21 231:13 233:12 235:6273:2
deals [1] 195:18
dealt [4] 95:11 114:19 199:17 303:
8
death [11] 17:15 43:16 73:9 97:18,
22 98:3 187:11 213:22 218:4 220:
2 230:8
deaths [8] 10:21 22:6,14 49:1 73:8
228:13,16 261:5
debate [3] 77:7,20 228:8
debated [2] 62:17 63:21
Debra [5] 2:22 3:9 6:9 9:10 21:6
decade [2] 48:17 174:12
decades [2] 27:12 293:18
deceased [1] 152:9
decide [1] 40:3
decided [1] 140:4
decision [6] 25:4 165:5 166:12
200:5 219:19 246:1
decision-making [1] 172:13
decisions [1] 24:20
decline [14] 31:17,19 32:17,19 33:
12,15 34:5 36:11,22 164:18 165:9,9 169:17 183:18
declines [2] 159:21,22
declining [1] 35:22
decompensate [1] 74:8
decompensated [70] 13:10 49:15
76:16 78:20 80:4,17 111:2,8,9
115:9 119:19 120:3 126:3,8,10
127:10,13,20 128:15 134:16 145:
7 150:8 151:9,11 153:18 197:9,22
198:3 202:21 203:2,22 204:2,20
206:15 208:3,12 209:9,14 210:5
212:5 213:4,14 218:20 219:6,20
220:12,13 224:3,7,7 225:4,17 226:
1 228:6,22 232:1,14 233:2 258:11
263:22 270:9 273:7,8,19 274:1276:1 278:19,22 295:14 298:10
decompensatedB-it [1] 126:1
decompensation [15] 48:2 54:14
55:2 79:7 80:1 88:11 93:4 127:15
150:13 151:10 195:5 217:5 218:2
225:5 274:19
decrease [2] 49:16 61:14
decreased [4] 34:2 56:16,17 128:
7
decreases [1] 49:14
decreasing [5] 61:10 108:13 124:
19 166:17,18
decrement [1] 71:10
deeper[1]
186:6deeply [2] 155:18 161:12
defensible [1] 252:14
defer [2] 167:2 288:11
deferred [4] 14:2 118:12 134:9
139:6
deficits [2] 72:12 136:17
define [13] 26:4 64:11 65:1,2 92:9
93:21 178:9,10 236:6 243:3 252:5
253:9 281:8
defined [11] 26:14 37:20 55:9 56:8
95:22 120:19,20 123:7 147:2 150:
18 277:9
defines [1] 21:22
defining [4] 64:5 158:12 236:10
252:3definite [1] 200:5
definitely [2] 245:7 306:4
definition [8] 47:7 77:22 115:12,
14 116:6 121:4 130:14 160:12
definitional [1] 117:1
definitions [6] 107:21 110:3,4,7
116:13 159:11
definitive [4] 44:16 123:16 177:12
268:22
degree [5] 27:6 125:12 154:5 166:
7 268:21
degrees [1] 194:8
dehydrogenase [1] 62:10
delay [8] 118:15 119:3,20 206:9
230:15 243:5 260:8 288:22
delayed [1] 177:12
deleterious [2] 209:8 242:16
deliberate [1] 229:3
deliberations [1] 7:2
delineating [1] 303:6
delivered [1] 292:14
demand[1]
294:13demanding [1] 294:14
demographics [1] 188:2
demonstrate [4] 133:12 137:9
142:1 257:8
demonstrated [8] 18:12 28:17 38:
9 110:21 112:20 115:2 132:12
140:20
demonstration [1] 58:15
DEPARTMENT [1] 1:1
departments [1] 87:4
depend [2] 263:12 285:4
dependent [2] 14:12 15:8
Depending [13] 44:22 56:3 118:10
130:18 134:21 172:6 174:14 199:
11,12 207:17 238:6 251:18 308:20
depends [3] 14:3 97:19 218:22
Deputy [1] 6:7
derive [1] 42:6
derived [5] 22:20 41:2 58:2 170:9
228:4
describe [1] 191:8
described [1] 210:2
describing [3] 32:19 251:18 253:
22
deserve [1] 194:3
deserves [3] 106:16 199:22 276:
13
Design[42]
3:14 6:21 12:18,21 14:1 15:15 50:9,12 51:13,20 66:12
88:7 92:12,16,19 95:2 96:15 103:
10 105:17 129:18,20 130:4 140:
14 145:15 191:4 209:16 215:6
224:10 225:3 228:7 239:11 253:
17 254:3,3,5 255:20 267:17 276:
12 278:2 279:12 280:18 282:19
designated [1] 5:9
designed [8] 157:20 225:9 248:3
250:17,21 257:12 267:21 311:4
designing [3] 88:7 251:11 274:3
designs [13] 14:7,10 59:5 75:17
77:4,18 79:5 80:16 105:11 167:1
185:14 309:8 311:19
desirability [1] 143:22desirable [2] 167:17 219:9
desire [1] 218:10
desires [1] 242:5
desk [1] 172:3
desperate [1] 219:3
desperately [1] 214:18
despite [2] 65:3 100:8
destined [1] 152:16
detail [3] 156:10 168:3 191:8
details [1] 263:7
detect [1] 305:3
detectability [2] 34:22 144:22
detectable [2] 116:3 161:3
detection [1] 63:12
deterioration [1] 204:4
determination [1] 157:15
determinations [1] 166:20
determine [2] 41:19 172:7
determined [2] 64:16 303:1
determining [1] 20:5
devastating [1] 112:9
develop[19]
22:12 29:9,12 37:1345:12 48:5 50:21 55:22 74:5 90:8
128:14 164:13,16 165:11,13 166:
11 182:14 206:21 215:1
developed [5] 39:20 128:17 140:1
206:10 246:21
developers [2] 185:3,12
developing [5] 164:17 168:20 169:
22 182:21 290:14
Development [39] 3:8 5:22 6:21 9:
12,14 10:12 11:4 12:14 21:9 45:
16 51:15 72:17 80:12 90:14,22 91:
2 96:21 103:5 114:22 117:7 130:
11 135:6 149:16 180:13 181:4,6
185:19 186:3 189:13,22 206:7
209:7 211:10 232:19 241:9 260:19 266:16 300:15,17
developments [2] 83:9 241:21
develops [1] 190:7
devices [1] 4:11
devil=s [2] 207:2 248:1
Di [1] 44:20diabetes [2] 104:12 188:10
dialysis [2] 80:21 311:9
dictating [1] 72:14
didn=t [11] 38:2,18,20 42:22 122:4
126:14 135:20 146:15 213:22 259:
17 296:13
die [7] 27:21 28:6 45:17 213:14,19
215:7 231:20Diego [1] 5:13
difference [26] 33:10 36:20 37:8
42:11,14 52:8,22 53:1 54:2 117:5
119:2 121:7 128:21 144:20 182:9
213:2 214:13 219:3 234:15 253:
19 277:6 287:4 294:6 301:7 303:
11 305:20
differences [9] 21:3 34:4 53:3,20
71:17,19 143:9 219:5 306:13
different [72] 19:20,20 20:1,17 33:
17 36:17 38:8,8,11 41:22 42:16,
17 43:21 69:16 85:19 93:16,19,22
99:12,21 114:12 116:17 119:10
132:11 133:10 140:1 145:13,16
147:5 151:14,16 162:17,21 179:18,19 181:11,13 183:6 188:5,14,
15 207:12 208:2,5 221:12 223:17
226:12 238:12,15,22 239:8,10,11
240:6 245:21 247:10 265:18,20
277:12 279:1 287:12 294:7 295:
13,13 297:22 298:3 299:9 300:22
301:2 309:18,20 310:11
differential [10] 29:12 37:10 69:7
117:13 138:22 139:8 158:8 164:
14,21 266:3
differentiated [3] 116:18 120:2
Sheet 7 cyclosporin - differentiated
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 8/28
122:22
differently [4] 42:3 98:14 117:8
304:18
differing [3] 107:8 121:12 133:9
differs [1] 72:22
difficult [35] 90:7 92:17 114:10
115:4,15 134:1 143:13 144:18
174:17 178:19 187:13 189:17 192:
11 193:14 201:6 218:8 219:13
220:22 221:4 224:5 237:16 244:6
252:2,5,7,8 262:9 272:13 275:19280:17 281:19,20 283:8,19 309:
15
Difficulties [4] 3:14 15:16 50:9,12
dig [1] 186:6
Digestive [1] 3:18
direct [6] 49:5 62:22 159:21 160:5
183:13 241:8
directing [1] 77:6
direction [2] 302:2 303:18
directions [1] 122:2
directly [2] 22:14 184:22
Director [7] 3:10,18 6:8,10 16:8,
13 83:17
Director/Founder [1] 3:21
disagree [1] 203:21disappeared [2] 149:14 159:2
disclaim [1] 52:1
disclose [1] 8:13
disclosure [1] 180:6
discontinuation [1] 73:20
discounting [1] 144:15
discovered [1] 198:9
discovery [2] 169:7 224:13
discretion [1] 24:6
discuss [14] 4:5 6:20 7:2 12:14 37:
12 53:14 64:12 142:18 143:5 146:
20 155:21 157:13 178:8 205:12
discussed [17] 7:7 21:2 78:13 94:
3 98:18 144:14 151:21 190:3 197:3 234:22 246:19 258:12 273:11,
18 275:10 277:15 280:11
discussing [7] 10:11 19:2 50:8 84:
7 110:14 235:10 293:6
discussion [33] 9:16 16:20,21 25:
3 40:5 51:7 52:4 74:20 77:6 82:18
97:17 139:14 150:4 154:10 155:6
156:8 157:10 159:20 162:13 163:
11 170:5 196:20 229:22 233:21
241:5 258:8,13 264:2 272:4 298:9,
10 302:1,19
discussions [11] 8:10,20 15:20
17:2 26:21 106:11 174:8 180:18
234:22 263:12 302:4
disease [116] 5:17 17:17,21 18:323:9,20 24:13 28:22 29:2 45:11,
13,15 46:16 47:21 48:3 49:15 50:
21 51:2 52:9,16 56:22 66:20 73:8
74:15 77:1 78:22 82:10 89:17,18,
21 90:3 101:14 108:12,15,16,19
110:13,19 111:7 112:4,4,9 113:22
119:19 120:2 124:11,20 126:4,6,8
127:7,10 128:17 135:12 136:4
137:17 143:11 144:5 151:19 162:
4 163:6 174:14 175:1 180:11 181:
14 183:3 184:7 187:10 194:14,14
196:14 197:8 199:16 200:14 202:
16 203:2,16,17 204:5 212:6 218:3
219:20 222:4 223:10 228:4,6 230:
7,9,21 231:10,14,21 232:1 233:2
265:6 274:8 276:1,8 279:17 280:5
285:10,13,14 286:10,14 292:21
293:5 298:11,14,20 300:7,22 306:
21 309:11 311:2,18
diseased [1] 153:17
Diseases [12] 3:18 5:2,7,12,15 16:
14 51:5 55:15 76:21 87:15,18 95:5
disorders [2] 312:11,17
disparate [1] 114:15
disparities [1] 73:19
disparity [3] 72:7 107:5 204:9
disproportionate [1] 307:11
dissolution [1] 51:3
dissolve [1] 61:18
distinct [3] 153:21 192:19 235:20
distinction [3] 184:20 237:7 251:
22
distinctions [1] 186:2
distinctly [2] 236:9,22
distribute [1] 245:20
distribution [1] 20:16divergence [2] 20:9,22
divergent [1] 119:15
diverse [1] 188:20
divide [1] 215:16
divided [2] 113:7 236:15
Division [12] 3:10,18,25 6:6,9,10
121:6 130:10 132:22 135:8 186:4,
5
doable [1] 201:3
dockets [1] 8:1
doctors [1] 102:12
doctors= [1] 126:6
document [1] 191:10
documented[4]
76:5,9 116:4,7documents [1] 7:22
dodged [1] 146:12
doesn=t [19] 31:19 38:21 60:12 88:
22 91:13 92:1 158:19 165:17 208:
13 236:17 247:21 248:11 256:13
257:3 297:11 298:13 301:12 309:
16,18
doing [24] 32:21 63:1 94:15 96:13
103:16 128:9 137:10 142:9 154:7
177:21 178:17 201:12 220:20 241:
14 253:9 254:17 255:11 256:18
262:3 278:6 281:19 301:15 304:
21 307:3
dollars [2] 49:7 88:16
dominate [1] 66:15don=t [109] 31:21 39:1,1,5 41:4,10
43:17 46:21 53:22 79:9 84:7 92:9,
19 94:7,22 95:12 96:20,22 97:15
99:7,15 101:4 102:4 103:19 104:3
110:10 111:3 132:8 136:7,19 139:
20 143:3 145:4,8 146:13 147:4,15
153:9 155:17 157:4 164:12,20
165:11,12 168:15 176:12 177:10
178:6 191:7 193:9 194:9 195:7
197:19,19 198:11 202:5 207:10
214:3,14 220:17 221:12 223:8
224:15 230:15 231:12 233:18 242:
7 244:9 245:5,9,19 249:22 251:3
253:10 254:4 256:14 258:7 260:
11 261:4 264:5 270:11 271:16
277:14,19 278:14 282:20 283:12,
22 285:4,7 288:17,21 289:1,18
290:8 293:5 294:17 297:10,13
299:6,7 300:1,21 304:12,13 305:6
310:19 311:12 312:7
donated [1] 276:11
donation[1]
204:10done [51] 4:8 39:16 67:16 68:10
73:14 77:3 122:7 133:15 136:6
170:8 175:16 192:22 194:11 197:
10 199:8 200:21 204:2 206:13
221:7 222:9,13 226:8 236:21 237:
18 247:15,21 256:9 258:21 260:
18 261:6 264:22 270:19 276:18
280:6 283:7,14,16,21,21 285:5,5
296:15 297:2,12 298:7 306:1,3,5
309:18 311:21 312:18
donor [4] 152:9,9 214:13 223:9
dormant [1] 144:11
dose [19] 14:17 71:2,8,8 78:5 131:
10 150:15,15,21 178:22 223:4
255:7,12,22 256:4,12 278:16 299:11,17
dose-response [1] 163:22
doses [5] 73:21 150:16 184:17
275:16 301:9
dosing [4] 69:8 81:5 170:22 191:
21
dossier [1] 177:4
dots [1] 34:19
double [2] 48:22 87:10
doubt [1] 97:16
Doug [2] 7:20 261:19
Douglas [2] 2:6 5:14
down [14] 26:12 31:8 33:12,15 34:
2,3 42:22 101:7 165:19 169:11263:5 285:21 297:6 300:14
downside [1] 147:18
downstream [1] 242:17
dramatic [3] 48:19 224:10 301:7
dramatically [8] 22:5 223:17 226:
12 297:22 298:3 299:9 300:22
301:2
drift [2] 19:10,10
driven [1] 242:4
drop [11] 26:11 30:10 33:13 35:11
40:17 55:2 58:4 63:16 70:9 165:
19 282:14
dropout [1] 310:10
dropped [1] 22:5
dropping [1] 165:14drove [1] 298:9
Drs [1] 7:18
DRUG [140] 1:2,3 3:8 6:19 7:16 9:
12,14 10:11 12:14 24:18 31:20 42:
7,8 59:10 70:22 72:16 77:9 78:7
80:12 85:3,4 90:22 91:1,8,9 92:5
93:6,10 94:5,11,14,21 95:15,18
96:13 97:5 98:7 99:1 103:6 105:9,
18 115:1 118:16 138:12 155:2
162:10 164:4,9 165:21,22 169:7
172:11 185:3,6,12,19 186:3 187:
15 189:7 190:5 197:21 205:19,20
209:6 212:12 217:21 218:22 221:
5 222:7 223:4 224:18 227:20 230:
7,15 231:4 233:1,3,4 234:16,17
239:21 241:8,20 242:3 245:8 247:
17 249:1,5,15 250:20 252:16,18
255:14,15 259:18 260:19 261:3,
16 263:21 264:17,19,22 265:20
267:9 268:11 269:2,9,13,17 270:
17 277:2,13,16 278:6 283:5 285:8
288:18,22 289:2,3,16 294:10 296:9 297:10,18 299:12,12,14 300:15,
16 301:6,6,9,9,12,14 304:2 311:5
312:10,16
drug-drug [4] 259:5 260:3,16 277:
9
drug-suppressed [1] 162:1
Drug-to-drug [2] 133:17 187:21
drug=s [1] 198:2
DRUGS [99] 1:4 3:4 4:4 11:4 19:1
23:14 30:19 32:11 55:22 60:1 69:
8 89:16 90:7,8,12,14 91:3,7 93:2,
9,13 95:21 96:14,22 97:9 102:4,
21 105:10,19 133:18 138:16 142:
1 143:8 151:14,16 160:17 170:12,
18 174:22 175:13 179:18 181:8188:15 189:12 195:12 199:19 205:
15 206:21 207:1,3,22 219:1,4,10
221:2,13 223:16 227:14 239:2,4
240:20 241:12,13,18 242:6 245:5
250:17,19 251:6,11 256:4,22 257:
11,20 260:17,20,22 263:1 265:18
266:16 268:13,13,14 272:20 282:
4 284:2 285:6,20 288:20 289:21,
22 290:21 291:3 293:11 295:4,8
299:4,16 301:2
dual [1] 57:22due [10] 58:4 74:15 76:20 82:22
127:13 204:4,22 231:5 276:1,8
durability[3]
100:4 135:15 141:13durable [4] 64:7,7 135:18 163:9
duration [21] 14:18 39:3 66:20 68:
16 71:9 73:17 78:15 118:15 119:
10 121:4 131:12 135:10 156:19
170:22 192:20 224:9 251:20 252:
10,11,20 255:3
durations [4] 119:2 121:12 139:7
160:11
during [7] 4:12 32:2 39:9 160:2
181:5 183:12 185:6
dying [2] 102:18 217:12
dynamic [3] 28:7 45:8 55:20
dynamics [6] 27:15 158:15 180:20
224:18 227:6,9
Eeach [20] 7:15 10:18 19:22 20:5 35:
5 56:15 129:19 133:12 172:1 197:
6 201:2 206:4 230:3 241:6 246:20
293:22 295:19 296:1,16 305:3
eaerlier [1] 121:18
earlier [30] 43:16 55:8 69:9 108:21
109:1 116:15 118:19 123:6 125:9
126:11 134:6 135:11 153:19 154:
12 159:20 181:22 187:7,15 235:
16 236:11 259:1,5 265:6 270:9
292:20 298:10,21 306:8,14 312:
Sheet 8 differentiated - earlier
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 9/28
12
earliest [3] 70:12 80:14 189:1
early [56] 26:8 29:11 31:3 32:13 34:
5 35:17,17 36:21,22,22 38:17 43:
11 44:2 63:17 64:10 65:7,18 70:
10 72:3 97:6 98:16 102:14 113:9
123:16 149:17 154:18 160:4,14
166:1 168:1,10 169:7 170:15 174:
14 176:11 179:1,14 183:18 187:
18,21 192:17,18 217:10 232:19
233:2,5 241:18,20 259:3,19 260:18 262:14 268:9,18 282:8 286:19
ease [1] 253:16
easier [8] 201:4 238:7 241:1 249:1,
14,15,19 296:10
easiest [6] 201:21 202:1 221:22
264:15,18 297:17
easily [6] 206:10 212:22 234:1 251:
20 290:22 291:7
easy [4] 200:20 225:21 249:22 264:
4
ebb [2] 282:11,12
echo [1] 158:3
edges [1] 67:22
Edlin [1] 22:16
education [1] 86:22educational [1] 86:8effect [13] 38:6 61:4 81:6 100:20
104:13 160:6 167:10 170:13 203:
20 209:8 217:4 290:15 302:12
effective [13] 30:20 44:15 49:13
50:22 109:14 190:1 199:19 203:5
221:14 232:15 275:5 285:9 296:
11
effectiveness [4] 63:6 73:2,5 220:
14
effects [11] 61:1,3 132:20 153:9
196:2 200:2 222:1 255:16 268:16
290:20,20
efficacious[6]
33:11 36:13 83:4132:12 229:6,14
efficacy [43] 11:18 31:3 33:5 58:5
80:15 83:1 91:9 93:1 96:7,10,19
98:6 103:18 104:11 115:2 130:18
145:8 177:5 224:14 228:11 229:
12 248:2 251:15 253:2,9 256:1
261:14 267:7 268:19,22 269:1,7
271:13 275:3 277:4 285:22 288:
10,14 303:1,6,7,22 305:3
efficiency [6] 31:3 33:6,21 34:5
35:8 187:22
efficient [4] 31:20 184:18 205:21
267:16
efficiently [2] 38:12 44:4
efforts [4] 192:16 217:9 268:8 311:16
eh [1] 78:16
eight [2] 148:4 291:7
either [15] 25:11 143:8 144:2 147:
17 148:7 183:2 213:21 232:6 240:
6 255:6,7 256:4 259:11 275:16
310:19
elapse [1] 279:2
elect [1] 141:17
elects [1] 137:7
elegantly [1] 183:8
element [3] 211:22 224:21 248:5
elements [3] 55:1 59:13 142:13
elevated [4] 53:21 54:16 75:3,19
ELI [1] 181:19elicit [1] 181:21
eligible [2] 253:20 279:18
eliminate [4] 23:17 81:14 100:16
176:17
eliminated [2] 84:22 162:9
ELISA [1] 26:7
eloquently[1]
302:7elsewhere [1] 144:6
elucidate [1] 154:11
email [1] 86:12embark [1] 50:4
embraced [1] 143:21
emerge [1] 118:17
emergence [3] 26:5 235:7 267:11
emergency [2] 24:1,8
emerging [1] 82:20
emphasis [1] 101:17
emphasize [1] 102:2
emphasizes [1] 66:8
emphasizing [1] 18:4
employed [2] 124:12 125:2
employee [1] 8:19employees [1] 7:18
employment [1] 189:18
empty [1] 280:2
enable [1] 181:1
encephalopathy [2] 45:14 110:20
encompassed [1] 258:10
encompassing [1] 250:14
encouraged [1] 284:12
encourages [2] 172:18 173:6
encouraging [1] 309:7
end [23] 18:17 20:11 23:6 30:7 42:
8 51:18 54:11 65:7 68:10 76:9
108:3 116:13 117:11 122:6 147:
20 152:18 163:11 176:8 197:5223:9 276:1 300:18 308:15
end-of-treatment [1] 292:1
end-stage [11] 45:13,15 47:20 48:
3 108:16 124:20 128:16 135:12
136:3 187:9 311:2
endeavor [1] 11:5
ended [1] 201:1
ending [1] 200:13
endorsement [1] 118:20
endpoint [28] 47:13 51:21 54:21
67:8 77:19 121:1 122:20 124:6
127:17 129:12,13 136:2 139:11,
14 145:19 146:10 155:20 156:21,
22 157:1,4 158:8 159:11 166:20
238:6,15 239:8,10endpoints [46] 7:4 12:21 15:3,5,6
78:8,16 79:17,18 80:18 81:8 82:7,
8 99:11,12,14,16,18,18,19,20 120:
1,4,11,15 121:13 122:19 125:3,16,
18,19 128:14 129:8 140:3,3 155:
20 169:1 181:3 185:14 196:4,5
236:7 238:21 243:4 252:3 308:2
endpointsB-as [1] 196:6
ends [1] 53:4
engender [1] 82:18
England [1] 153:20
enhance [2] 183:1 309:21
enhancement [1] 184:12
enjoy [2] 145:10 161:11
enlarging [1] 225:1
enough [10] 40:8 67:12 124:11
126:8 144:21 205:21 227:17 233:
9 261:2 264:6
enroll [5] 84:19 114:10 115:5 241:1 305:22
enrolled [5] 13:1 259:16,19 291:
22 306:3enrolling [1] 246:12
enrollment [4] 115:18 291:22 309:
2 310:9
ensure [3] 172:14 189:21 267:19
ensuring [1] 308:19
enter [1] 259:9
entering [3] 50:1 62:7 174:18
entertain [1] 77:4
entertained [1] 77:5
entertainment [1] 204:1
enthusiasm [2] 131:19 141:6
entire [1] 111:21
entirely [1] 248:20
entry [3] 18:18 300:13 309:21
envelope [1] 18:20environment [3] 60:15 62:22 170:
17
Enzyme [3] 25:5,9 230:5
enzymes [3] 25:20 26:11,12
epi [1] 16:19epidemic [1] 22:1
epidemiologic [2] 27:9 245:22
Epidemiology [5] 3:11 15:13 16:2,
14 17:8
epithelial [1] 59:8
epitope [3] 55:9 182:5,12
epsilon [7] 31:2,6 33:6,18,20 58:
16 161:18
equal[5]
66:11 116:2 212:21 251:14 286:12
equals [2] 28:14 29:15
equation [4] 29:13,17 30:6 31:5
equation-based [2] 164:14,22
equations [3] 29:10 31:15 42:4
equilibrium [3] 28:15,15 29:10
equivalence [2] 248:18 255:10
equivalent [6] 249:2 250:3 252:16
255:5 256:5 290:19
era [2] 174:18 250:16
eradicate [1] 124:18
eradication [5] 120:7,10,12 144:2
175:8
error [1] 19:9
errors [1] 44:6especially [5] 170:18 209:20 222:
3 228:17 307:19
essential [1] 285:3
essentially [10] 83:5 86:20 119:6
127:2 130:4,21 132:9 176:4 210:
18 253:22
establish [3] 103:17 134:10 269:
12
established [3] 27:6 183:3 269:1
establishment [1] 26:13
esteemed [1] 186:9
estimate [4] 22:6 23:6 86:13 307:
8
estimated [3] 22:7 48:15 49:4
estimates [7] 10:18 22:13,20 23:5
48:19 54:17 64:8
etc [8] 151:17 168:9 220:15 221:18,
18 266:22 296:4,4
ethical [1] 215:14ethically [1] 214:5
ethics [4] 214:6,8,8 241:14
ethnic[12]
13:18 76:12 112:20188:20 258:15 301:22 302:4 303:
19 304:1 307:16 311:1,17
etiology [2] 17:21 21:12
ETR [1] 76:8
Eugene [3] 2:10 5:22 8:14
evaluate [2] 150:10 192:20
evaluate-Band [1] 30:22
evaluated [2] 267:12 312:1
evaluating [2] 101:14 211:1
EVALUATION [8] 1:3 6:19 25:13
155:9,12 158:5 267:8 268:15
Evelyn [1] 307:6
even [32] 6:16 11:16 42:16 43:2 47:
10 60:18 68:15 84:8 98:20 112:21
117:10,12 120:10 128:3 144:17149:13 153:21 186:2 196:8 221:
17 224:9 228:10 230:6 237:11
239:11 247:4,6 249:18 250:5 298:
16 307:1 308:17
event [3] 8:20 82:1 210:17
events [5] 76:19,20 86:8 87:8 211:
1
eventually [3] 26:5 149:8 165:15
eventuate [1] 274:17
Everson [1] 274:10
Everson=s [2] 150:14 151:5
everybody [7] 88:5 92:6 99:15
138:7 180:5 199:22 206:21
everyone[18]
17:3,7 46:18 64:18109:8 114:19 120:8 121:2 130:10
132:5 175:10 216:10 243:8 244:
18 257:21 269:2 284:13 312:8
everything [4] 85:21 105:22 246:3,
4
evidence [10] 23:20 70:13 110:8,
19 192:21 194:10 204:19 229:6
246:22 274:11
evident [1] 160:8
evoke [1] 58:13
evolve [1] 256:20
evolved [1] 39:8
EVR [3] 123:21 165:8 261:15
EVR12 [7] 124:5,14 130:8,14 134:
12 139:19 140:16exact [1] 299:22
exactly [8] 32:2 92:10 132:8 156:
12 226:21 263:2 271:16 299:19
example [12] 42:1,4 91:15 105:4
164:1 165:21 173:2 222:19 223:1
226:1 263:15 285:9
exceedingly [1] 309:4
excellent [9] 65:14 67:2 146:16
156:16 159:4 161:9 171:1 194:6
203:7
except [7] 52:14 97:19 125:17 135:
Sheet 9 earlier - except
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 10/28
10 140:3 178:11 275:6
exciting [3] 50:2 174:19 181:5
exclude [2] 179:2 201:5
excluded [1] 311:3
exclusions [1] 9:2
exclusive [3] 56:6,9,14
Excuse [1] 203:5
Executive [2] 3:21 83:17
exhibit [1] 35:14
exist [2] 20:11 44:1
existence[1]
55:4existing [1] 52:11
exogenously [1] 59:10
expand [1] 81:18
expanded [5] 85:5,11 93:13,18 94:
1
expanding [1] 217:8
expect [10] 38:1 107:4 135:20 160:
13 191:22 225:19 246:4 260:11
287:22 308:12
expectancy [3] 54:22 55:3 276:8
expectation [1] 262:22
expectations [1] 68:15
expected [1] 238:10
expenses [1] 173:4
expensive [1] 109:11Experience [12] 3:14 35:7 50:8,12
100:8,10 104:4,18 151:1 220:17
236:13 309:20
experienced [16] 13:7 14:5 52:2
140:18 233:11,14 234:5 235:14,
15 238:5,21 244:14 246:17 273:2
308:9 310:2
experienced-patient [1] 239:7
experienced-treatment [1] 217:
22
experimental [3] 207:21 212:4
213:16
expert [1] 198:4
expertise[1]
267:19explain [3] 29:6 39:19 72:9
explanation [3] 58:18 106:16,17
expose [1] 133:1
exposed [4] 44:22 181:17 182:1,
17
exposure [11] 23:22 24:1 25:19
144:17 164:5 242:13 297:5 299:
12 301:6,9,14
exposure-response [5] 163:20
164:9 263:14,17 264:3
express [1] 198:8
expressed [2] 135:9 306:7
expressing [1] 198:17
expression [1] 61:11
extend [5] 68:12 77:21 167:18 168:3 279:6
extended [7] 27:11 78:4 130:9,12
168:11 242:20 308:18
extending [1] 224:6
extension [1] 262:9
extensively [1] 273:11
extent [3] 169:6 206:6 256:19
external [1] 46:7extra [6] 122:2 269:18,20 270:19
294:7,8
extrahepatic [1] 51:2
extraordinarily [3] 191:18 194:4
275:20
extrapolated [1] 170:9
extremely [8] 19:5 40:19 44:9 50:
2 55:4 72:20 95:1 160:4
FF.A.C.P [1] 3:16
F4 [1] 69:12
face [2] 102:12 181:5
faced [1] 242:5
facilities [1] 4:15
facing [5] 95:18 236:14 239:21
243:15 248:13
fact [50] 23:7 25:22 27:6 30:11 35:
1 37:9 38:12 40:19 41:11 43:11
57:1 58:19 64:7 67:10 73:13 95:5
130:17 149:12,14 150:1,1 151:5
152:13 157:22 174:3 175:16 182:
20 196:11 199:3 207:5 214:11
215:14 222:22 223:6,11 231:13
232:16,21 233:7 235:5 242:19
249:13,19 250:2 256:3 257:12
289:14 299:8,10 307:7
factor [5] 70:1 194:15 195:9 259:2
293:6factors [13] 23:11,15,16 24:7 46:7,
17 61:13 144:16 160:16 221:5
267:7 286:11 287:3
fail [3] 43:6,6 137:2
failed [1] 116:1
failing [1] 14:14
fails [2] 35:13,16
failure [6] 22:6 76:22 80:20 164:2
191:15 194:3
Fair [1] 233:9
fairly [8] 17:17 33:10 41:12 160:18
166:7 231:20 242:20 249:11
fairness [1] 9:4
faith [1] 242:12
fall [2] 25:1 134:17
familiar [2] 142:22 143:3
families [2] 290:6 293:9
family [3] 62:15 230:5 287:6
far [13] 74:14 93:17 101:14 113:13
117:20 193:4 217:16 247:11,15
273:1 289:11 292:13 296:7
fare [1] 76:2
fashion [4] 96:14 205:17 297:12
300:10
fast [5] 85:13 91:3 93:9,12 228:11
fastest [3] 113:18 138:5 224:12
fat [1] 47:2
favorable [2] 82:2 128:10
favored [1] 127:17FDA [32] 2:21 3:7,10,25 6:8,10 8:3,
8,22 9:10,13 13:2 83:22 84:3 85:6,
6,12 92:20 95:21 96:16 97:2 172:
15,18 173:5 226:6,8 230:1 250:7
283:11 295:9 299:16 309:7
FDA=s [2] 7:22 8:12
fear [1] 118:19
feasibility [1] 214:7
feature [2] 165:15,16
features [2] 122:8 267:4
federal [1] 5:10feedback [2] 4:9 108:6
feel [20] 4:14 77:10 118:14 122:16177:2,3,10,14 179:17 188:6 191:8
212:3 222:5 226:21 244:12 250:
13 280:19 291:2 297:14 300:12
feeling [6] 197:7 222:11 244:11
268:7 285:16 301:17
Feigle [1] 85:14
fell [1] 154:21
felt [4] 119:15 122:5 136:11,15
fences [1] 163:7
Ferenci[1]
70:7few [17] 4:5 26:9 32:18 34:15 44:
19 55:16 90:20 119:18 126:2 168:
16 203:8 231:7 276:10 286:6 287:
22 295:1 301:10
fewer [2] 113:2 200:2
fewest [1] 222:1
fibrogenesis [6] 52:22 60:19 61:
14,15 68:13,18
fibrosing [1] 284:8
fibrosis [20] 45:20 51:3 53:4 61:10
67:3 69:9,11 128:6 147:16,17,21,
22 148:20 166:18 167:5 194:8,21
195:10 231:18 281:12
fibrotic [2] 46:6 67:20
fidelity [1] 135:5field [3] 49:22 85:2 155:18
figure [6] 97:3 105:17 133:2 243:
11 289:8 306:17
figures [5] 10:15 11:7 147:19 161:
18 162:6
fill [1] 302:14
filled [2] 302:9,16
filling [1] 12:2
final [2] 167:22 285:7
finally [12] 25:13 37:15 73:13 74:2
80:20 85:17 179:13 190:9 195:17
258:14 295:17,20
financial [7] 7:11 8:22 9:5 172:21
173:2,8,9find [12] 27:5 140:10 179:3 200:15
218:8 219:12 249:13 251:15 254:
5 261:12 272:7,11
finding [4] 47:12 135:19 236:11
308:15
findings [1] 185:4
finds [3] 69:17 73:8 74:11
fine [2] 121:20 297:15
firm [1] 9:5
firms [1] 8:21
First [51] 4:6 32:15,16 34:15,18 35:
18 36:12,12 40:15 51:8 58:3 59:
16 67:9 84:12,18,19 86:8 104:16
111:6 116:7 119:6 126:9 129:20
147:7 159:21 169:8 174:5 198:14199:13 200:12 201:16 203:1 213:
20 218:18 237:3 239:4 241:7 256:
9,11,18 257:20 260:15 274:13
276:5,11 279:22 282:6,10,15 283:
11 297:9
Fish [17] 2:6 5:14,14 7:20 9:21 10:
2,5 166:12,13 216:6,7,8 258:22
292:15,16 310:20,21
fit [1] 44:2
fits [1] 218:7
five [21] 11:9 27:7 48:4 54:14,17
55:3 87:8 92:14 129:19 137:11
141:12 142:1 172:5 175:17 176:2
186:12 241:11 288:7 289:5 292:8
297:5
five-year [1] 126:12
fixed [6] 37:22 39:14 43:10 45:7
71:2 157:19
flat [3] 191:22 193:4 308:3
flavivirididate [1] 62:13
flavivirus [1] 62:15
flaviviruses[1]
18:10fleshy [1] 67:21
flexibility [2] 208:4,8
flip [2] 33:16 163:13
flow [3] 47:18,20 195:14
focus [11] 38:15 94:4 111:18 152:
15 174:3 176:14 181:8 202:3 217:
14 301:19 303:10
focused [1] 147:16
focuses [1] 174:20
focusing [3] 114:4 195:20 302:3
folks [3] 136:21 141:1 308:1
follow [7] 104:8,10 136:12 186:5
261:9 286:6 293:18
follow-on [1] 257:19
follow-up [22] 7:5 12:22 80:6,7 82:12 100:7 104:1,2 120:22 131:7,8
135:14 136:6,8 137:1,6 141:11,16,
18 155:12 156:14 168:1
followed [6] 15:14 26:22 105:5
136:19 157:21 168:5
following [17] 6:14 7:17 12:7 25:
19 27:7 39:16 43:11 45:4 115:14
154:19 155:9 169:2 171:8,19 172:
1 193:2 273:19
FOOD [4] 1:2 7:16 172:11 214:14
forced [1] 275:15
forecast [1] 207:11
foreign [1] 155:19
forever[1]
158:20forget [1] 312:2
forgiveness [1] 210:14
forgotten [2] 237:20 239:19
form [7] 28:8 62:9,12 106:10 107:2
132:10 257:17
Forman [1] 74:10
formation [1] 43:10
former [1] 312:10
forms [1] 19:11
formula [1] 206:20
formulation [3] 290:12 291:4 292:
13
forth [1] 196:2
forthcoming [4] 68:11,19 153:6
278:3forums [2] 86:6 87:6
forward [9] 17:12,13 21:17 50:11
101:18 102:6 186:3 229:2 266:12
found [3] 44:10 84:12 253:18
foundation [1] 263:12
founded [1] 84:13
founder [1] 83:17
four [16] 13:11 48:3 64:20 70:13
86:1 89:1 92:14 103:2 137:11 141:
22 142:12 149:9 166:4 236:3 282:
15 301:22
Sheet 10 except - four
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 11/28
four-week [2] 166:8 227:5
fraction [1] 131:3
frame [3] 229:4 242:7,21
framework [1] 38:11
frankly [2] 290:5 291:6
free [3] 4:14 153:9 183:16
Freedom [1] 8:6
frequency [5] 42:10,10 57:2 194:
20 307:20
frequent [2] 141:16 166:6
frequently[2]
203:12 278:13Friday [1] 313:2
Fried [1] 40:15
front [7] 157:20 196:10 199:10 214:
10 215:15 245:8 299:1
Frost [1] 49:20
full [11] 86:18 137:19 150:22 180:6227:17 256:12 263:3 280:2,3 302:
13 305:3
full-blown [1] 271:12
fully [1] 307:15
function [6] 110:21 126:18 127:14
128:19,20 204:21
functional [3] 14:14 18:20 47:5functions [1] 79:22
fundamental [2] 161:9 162:12fundamentally [2] 145:22 161:20
funded [3] 191:6 194:18 234:13
further [13] 17:1 33:13 40:20 83:6
114:15 141:11,17 151:22 154:11
199:15,16 247:5 295:16
futility [2] 40:21 41:4
future [8] 50:6 154:9 176:7 185:5
190:14 229:17 244:8 257:2
fuzzy [1] 211:17
GGalveston [1] 16:15
Gary [2] 41:1 49:10
gate [1] 239:5
gathering [2] 172:13 211:20
gauge [1] 70:17
gave [1] 306:17
gemischt [1] 191:17
gender [4] 201:12,13 308:18,19
genders [1] 188:13
gene [2] 56:8 61:12
general [17] 7:12,13,17 8:10,18 16:9 44:5 114:8 130:1 140:13 195:9
197:7 205:10 211:13 212:19 244:
2 273:4
generalizable [2] 207:11,14
generalize [2] 218:8 219:13
generally [5] 38:19 47:3 112:3
287:5 293:10generate [1] 44:15
generated [1] 34:17
generating [3] 36:19 44:11 82:4
generation [3] 26:7 50:4 256:17
genetic [3] 72:14 303:11 311:22
genome [2] 18:16 25:15
genotype [58] 13:11 20:12,19,19
25:14 38:21,22 58:20,21 66:9 69:
4,17 72:2 109:15 111:16,17 112:
22 113:10 114:4 118:10 174:16
188:2 199:12 202:8 229:15,16
231:17 240:13 244:19,20,21,21,21
245:14 246:13,18 247:4,5,12,16,
20 248:3,3 249:5,6,10,12 250:8
251:2,13 252:11,17,21 257:10,12,
14 304:4 306:19
genotypes [31] 18:11 19:17 20:1,
2,3,16 66:5,11,12,15 69:3 73:17
75:20 109:9,10 111:21 114:3 137:
21 143:1 148:19 188:1 199:1 202:
3,4,11 245:6,9 250:14,18 251:11
257:15
gentlemen[1]
174:1genuine [1] 135:6
gets [7] 53:12 64:18 94:21 161:9
228:17 234:15 240:18
getting [13] 96:14 220:4 232:3 238:
17 246:15 267:1,14 272:22 294:6,
16 296:8 298:21 310:2
GI [1] 290:1giong [1] 145:16
give [29] 10:1 25:8 33:3 39:6 44:16
59:10 75:14 84:11 93:10 107:7
119:7 122:1 124:5 131:6 142:10
149:16 154:3 157:8,12 165:20
172:1 195:6 208:21 210:21 216:
14 226:6 268:20 280:16 285:12
given [18] 26:13 27:22 33:4 41:1946:7 47:9 74:7 139:16 149:9 156:
2 158:13,18 261:15 266:18 276:6
301:6 307:19 308:3
gives [1] 36:10
giving [4] 92:11 119:14 167:15
185:22
glad [2] 83:22 84:3
glass [1] 280:2
gleaned [1] 126:15
global [1] 11:6globally [1] 10:17
Globe [1] 3:29
GlobeImmune [2] 180:8,13
goal[12]
100:14 120:5,11 122:21175:8,11 176:16,18 182:22 274:
12 291:22 295:21
goals [6] 50:20 107:6 126:16,21
302:10,17
god [1] 64:4
gold [1] 101:13
Gordon [1] 26:19
Gordon=s [1] 28:18
gosh [1] 123:2
got [6] 105:10 131:1 152:10 177:22
226:14 240:1
gotten [1] 155:2
Gould [1] 3:17
government [1] 7:18
grade [4] 67:2,13 69:12 125:5graft [2] 282:6,10
grant [1] 223:5
granted [1] 309:14
graph [1] 21:22
graphic [1] 181:18
gratigied [1] 153:13
great [14] 27:6 28:1 82:18 111:10
130:9,17 135:15 139:19 192:7
204:9 222:21 228:8 240:19 307:
10
greater [15] 11:15 19:6 26:14 36:
12 45:9 56:11,12,20 67:6 110:10
116:1 136:1 138:6 151:12 234:3
greatest [10] 66:13 75:2 78:21 113:
11,16 179:22 207:4 266:10,11
274:21
greatly [3] 185:12,19 301:10
green [3] 55:2 65:13 69:13
Greg [3] 150:14 152:14 274:10
Greg=s [1] 152:2
grew [1] 297:8
grey[1]
292:12groundwork [1] 261:21
Group [112] 5:5 21:16 22:21 26:22
28:18 37:11 38:2 46:11 47:14 52:
5 65:2,3,6,9,12 66:1 69:21 72:6
75:2 79:7,12,16 80:6,16 83:7 105:
10 107:4 111:14 113:15,19 115:3,
16,16 125:7 148:13 154:17 155:6
157:18 172:22 174:4 186:14,18
188:20 191:17 193:11 195:3,6
200:10 201:15,16,21 207:10 211:
11 213:13 214:9 215:12 217:16,
18 221:17,18,21 224:22 227:18
234:4 235:5,8,17,20,21,22 238:8,9
239:7 240:6 241:6,7 242:2 243:1
244:7,15 247:12 259:3,11,11,14,21 262:4,11 263:14 264:18 266:8
269:6 278:10 279:4,6,12,14,16,22
281:8 284:6,19 285:9 289:17 302:
14 303:13 304:11,20 306:11 308:
17 310:21 311:6
group=s [2] 173:3 234:11
grouping [1] 235:14
groups [46] 24:4,16 34:11 36:4 38:
8 42:17 71:17 72:5 76:12 112:20
114:10 116:16 122:21 147:5 155:
13 194:16 207:6 210:3,10 220:9,
12 222:7,9 225:4,18,22 227:10
234:16 236:10 237:19 238:13 241:
21 243:12 245:21 246:16 258:15264:20 302:1,4,19 303:20 304:1,
15 305:3 307:17 311:17
grow [1] 228:15
growing [3] 113:18 138:5 228:15
grows [1] 228:14
guaranteed [1] 225:8
guarantees [1] 103:6
guess [9] 103:1 132:5 150:4 176:
18 202:7,10 237:12 273:14 296:
17
guidance [2] 10:3 185:16
guide [1] 229:17
guidelines [1] 23:12
gun [2] 67:17,19
HHAART [7] 78:18 81:22 112:9 265:
6 266:13,13 277:16
HAI [1] 125:5half [9] 10:11 27:3,4 74:8 178:6
280:2,2,3 301:5
half-life [9] 58:12 68:4,9 82:3 160:
17 161:5,21 162:2 170:12
half-lives [2] 160:19 170:11
hallway [1] 173:16
halt [1] 211:10
HALT-C [4] 147:12,15 167:4,18
hammer [1] 97:14
hand [12] 7:12 53:12,12 207:9 214:
4 226:19 227:17 238:19 258:14
259:4 263:9,13
handle [2] 117:15 139:2
handled [1] 298:17
hands [1] 201:6
hang [1] 176:1
happen [9] 100:17 144:14 169:19
184:11 254:4 268:17 297:3 300:
10 306:19happened [2] 36:8 105:1
happening [3] 32:2 133:20 308:13
happens [4] 34:17 37:14 49:12
113:11
happy [2] 157:6,7
hard [8] 111:20 126:1 208:20 221:
4 223:14 239:8 309:21 310:3
harder [4] 209:8 249:18 259:22
294:13
harness [1] 182:22
Harvard [1] 5:20
hate [1] 283:5
Haubrich [25] 2:7 5:11,11 7:19
158:9,10 205:9,10 209:2 218:16
226:4,18,20 238:2,4 245:2,3 256:7,8 262:17,18 267:13,14 302:5,6
haveB-and [1] 92:8
haven=t [8] 37:20 106:1 173:13
234:21 240:1 271:20 275:5 283:7
Havens [54] 2:8 5:1,1 156:13,14
163:10 165:20 166:2 207:18,19
208:15,18,20 221:19,20 223:2,14
225:12,13 226:18 241:3,4 250:6,7
251:3 263:10,11 265:16,17 269:3,
4,17,22 270:4,7,14 271:2,9 284:14
288:3,4,8,15 293:21 294:4,21 295:
3,20 296:17 297:16 299:5,6 300:
19,20
HBV[5]
112:7,11 115:6 258:18282:5
HCC [1] 21:10
HCV [46] 3:16 24:11 25:10,12,13
26:8 27:1 35:5 36:17 40:18 44:19
50:14 51:9 52:7,9 55:11 58:1,4 59:
22 60:2 72:19 83:11 103:13 112:8
116:2 120:20 127:1 128:2 129:14
135:4,19 136:12 175:19 178:6
180:14 182:5 185:3,12 262:3 265:
7 268:5 276:16 282:14 286:8 300:
16 310:12
HCV-infected [2] 60:9 61:12
HCV-positive [1] 24:2
HCV-related [1] 48:22
HCV-specific [1] 185:2HCV/HIV [3] 34:13 262:2 267:5
head [3] 28:9 174:4 261:4
head-to-head [1] 132:15
headed [1] 148:13
HEALTH [13] 1:1 5:18,20 48:9 73:
4 87:4 144:4 153:15 170:20 189:8
293:15,16 298:22
health-related [1] 82:13
healthcare [5] 23:22 24:8 26:3
194:18 228:20
healthy [3] 273:20,20 293:14
Sheet 11 four-week - healthy
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 12/28
hear [5] 22:4 50:7 176:15 289:14
302:4
heard [12] 52:10 63:16 81:16,17
107:17 108:9 112:8 123:17 143:
20 187:14 226:5 233:20
Hearing [12] 3:27 15:19 84:3 85:6,
10 171:6,15,17 172:14,19 223:6
307:6
hearings [1] 95:22
heart [1] 213:22
heat[1]
23:16hedged [1] 121:22
held [7] 6:18 85:6 86:6 118:6 257:
1 283:22 308:17
help [10] 10:7 29:6 38:5 62:22 105:
19 140:9,10 175:20 179:5 216:4
helper [1] 56:7
helpful [4] 142:21 146:18 201:5264:17
helping [1] 10:9
hematologic [1] 290:20
hemodialysis [1] 23:19
hemodynamic [1] 205:1
hemolysis [1] 81:7
hemophilic [1] 27:10
hemotract [1] 68:7hence [10] 22:10 52:16 54:3 55:3
56:12,18 57:15 64:2 72:15 300:7
hep [13] 71:21 91:15 93:9 95:16
104:8 105:12 187:2 200:21 259:
13 271:21 307:21 310:14,18
hepatic [16] 51:1 52:9 61:10 126:
18 127:15 184:1,7,15 194:8 195:4,
10,14 196:7 219:5,7,10
Hepatitis [114] 3:8,11 6:22 9:11,14,
16 10:12,16,22 12:2,4 14:15 16:2
17:9 18:1,1,4 21:19 23:17 24:22
25:19,22 26:1 29:1 49:2 50:20 55:
7 57:14 58:8 59:7 60:21 63:9 73:1
74:13 85:17 88:21,21 89:2,2,5,6,16,17,17 91:1,3,18 93:14,17,20 95:
10,14 97:9,17,22 98:2,19 102:21
105:7 106:19 109:1,3 110:6,9,15
112:10,12,14 115:7 118:7 129:4,6
134:2 152:11 153:12 163:3 174:6,
10 180:12,15 181:6 182:12 184:2,
10 186:8,20 187:2,8 188:1 190:6
191:5 199:5 215:10 228:22 251:6
260:6 266:9 267:19 271:19 274:
16 280:10 284:9 286:1,21 287:11
290:6,12 299:8 304:21,22 306:14,
16,19 311:10
hepatocellular [17] 21:10 45:16
48:6,12 54:16 80:5 82:11 108:16
124:21 136:4 154:1 166:19 167:13 168:7,10,20 217:6
hepatocyte [10] 27:19,20 43:10,12
57:6 61:5 161:22 162:11 170:19,
21
hepatocytes [13] 28:3 30:13,17
32:7,11 52:10,13 58:12 59:8 62:8
64:1 162:2 170:14
hepatologists [1] 90:2
hepatology [6] 4:21 6:3 16:9 80:
11 174:3 290:2
here-Bof [1] 69:15
here-Bshow [1] 73:16
hesitate [1] 242:22
heterogeneity [3] 117:16 138:21
161:21
heterogeneous [4] 115:16 116:
16 138:4,18
HGV [1] 62:14
Hi [2] 4:20 190:19hidden [2] 17:11 135:19
high [32] 19:5 25:7 29:4 57:2 69:
17 70:15 73:20 76:17 77:1 78:591:18 113:10 135:4 151:6 166:7
170:2 174:16 177:16 194:4,16
210:12,20 211:1 216:15 232:15
242:6 267:6,12 289:3 298:11 307:
20 312:15
high-level [1] 186:1higher [20] 22:18 45:1,3 69:6,10,
20 72:5 146:8 177:12 194:22 235:
8 249:17 279:6 299:11,15,16 301:
8 307:10,10,11
highest [2] 75:22 200:13
highlighted [1] 88:13
highlights [1] 11:5
highly [12] 21:9 28:21 45:20 60:2
73:3 79:20 185:8 260:1 266:5 273:2 287:7 293:9
Hilton [1] 1:9
hinder [1] 206:7
Hispanic [1] 311:10
Hispanics [6] 114:7 304:9,10,17,
18 306:10
histologic [12] 15:4 47:7,12 54:8
113:9,20 125:4,18 129:15 140:2
196:5 246:10
histological [1] 54:1
histologies [1] 76:2
histology [6] 52:20 99:17 125:21
196:8 201:19 292:17
histopathology[2]
76:1 82:9historically [4] 20:21 115:4 210:
17 277:7
History [14] 3:11 15:13 16:2,20 24:
9,17,18 44:19 74:6 194:10,22 242:
21 312:11,17
hit [3] 4:7 91:7 250:16
hits [3] 91:10 92:5 98:7
HIV [102] 5:15 14:16 23:21 28:20,
22 36:18,21 46:3 72:19 73:1,4 76:
15 78:11,17 82:19 84:12,13,16 85:
18 87:16,19 88:5,17,20 90:4,22
93:3,15,16 94:2,15 95:4,4,7,11,13
97:10,17,19,22 98:11 102:14,17
103:15 105:9 112:7,8,10 115:6
125:9,11 158:19 187:2,9,11 190:6227:13 230:4,9,9 231:21 239:1
240:13,15 241:17 242:11 251:10
258:3,9,18,18 259:2,14,16 260:5,
11,18 262:8,10 263:4 265:3,11,19,
19,21 266:9,18 267:15,19 268:3,4,
18 269:8,10 277:1,16 295:7 296:3
298:10 300:15 306:3 311:8
HIV-positive [2] 187:11 265:5
HIV/HCV [1] 219:22
hoc [1] 39:16
hold [6] 96:21 159:12 220:3 221:6
243:19 283:5
holder [1] 124:4
holders [41] 12:16 14:9,21 15:4
106:18 107:1,14 108:7 111:13,19
113:6,6 115:13 116:12 118:5,21
119:5 120:14 121:6,7,20 122:3,9
123:2,5,10,11 126:2,15 130:1 135:
7 136:5,10,15 137:16 139:15 140:
8,22 154:12 194:1 198:10
holding [2] 84:3 203:21
holds[1]
71:14home [1] 97:14
homeless [1] 23:1
homes [1] 23:2
homogeneous [4] 113:13 138:2
251:1 297:17
honestly [3] 200:15 207:10 306:22
Hong [1] 129:5
Hoofnagle [2] 25:17 198:12
hope [7] 102:6 106:1 151:21 152:
17 153:4 160:1 255:8
hopeful [1] 186:4Hopefully [4] 17:12 82:8 229:5
288:1
horizon [1] 50:19
horse [1] 144:8Hospital [3] 16:9 194:20 214:12hospitalization [1] 97:18
hospitalizations [1] 98:3
hospitalized [1] 23:2
host [5] 59:13 75:11 77:4 180:22
181:14
host=s [1] 53:3
hostages [1] 312:8
Hotel [1] 1:9hours [4] 32:16 35:18 40:12 42:21
House [1] 89:4
housekeeping [1] 4:5
housing [1] 189:9
However[18]
11:11 37:21 42:1857:12 80:18 83:3 114:6 121:5 123:
4 128:9 129:8 138:16 145:18 176:
13 177:14 262:21 290:16 304:18
huge [5] 196:10 234:12,15 268:13
288:22
HUMAN [5] 1:1 96:7,9,11,17
hurt [1] 77:16
hypertension [2] 195:13 205:1
hypertensive [1] 167:8
hypotheses [5] 36:19 38:11 44:11,
12,15
hypothesis [2] 58:18 124:17
hypothetical [1] 38:10
Ii.e [2] 159:12 253:6
I=ll [1] 249:22
Ib [1] 180:11
ICAC [1] 104:17
ICC [1] 105:8
iceberg [3] 17:7,10 22:10
idea [10] 39:7 136:8 158:14 197:17,
20 198:11 210:21 230:12 266:14
282:10
ideal [3] 113:8 148:11 194:6
Ideally [4] 133:9 218:10,11 259:10
identical [2] 78:16 106:21
identifiable [2] 25:21 234:1
identification [1] 7:3
identified [4] 65:16 113:8 225:10
295:14
identify [5] 187:22 188:2 192:17
193:14 237:16
identifying [2] 246:12 281:11
II [1] 305:18IIb [1] 232:19
III [6] 22:19,22 211:15 215:22 232:
19 305:20ill [2] 214:1 231:20
illegal [2] 23:14 24:18
illustrate [1] 71:3
illustrated [3] 53:9 57:13 63:12
illustrates [1] 181:4
illustrating [1] 73:7
illustration [1] 181:18
illustrative [1] 64:21
imagine [1] 160:3
imaging-based [1] 47:11
immediate [3] 14:2 143:12 262:8
immediately [5] 35:10 68:10 160:
8 193:2 294:11
imminently [1] 200:14
immumomodulation [1] 160:6Immune [33] 3:29 29:21 52:16,18
53:11 55:9 58:13 59:1 60:6,7,12
61:6 63:7 68:7 72:12 100:19 136:
17 144:3 162:3 180:8 181:15,19,
20 182:10,14,21,22 184:6 185:1,2,
9 186:1 286:16
immune-based [4] 89:17,22 183:
6 186:7
immune-mediated [1] 57:5
immunoassays [2] 25:5,10
immunoblot [1] 25:8
immunoglobulin [1] 282:20
immunologic [6] 32:8,9 58:8 145:
16 161:16 182:15immunopathogenesis [1] 55:7
immunopathology [3] 56:11,21
60:17
immunosuppressed [1] 52:15
immunosuppression [3] 39:3
278:12 281:18
immunosuppressive [4] 56:5
277:3 278:17 281:17
Impact [24] 3:12 7:13 15:14 16:2,
20 17:9 53:22 66:13 74:15 76:20
79:1 117:19 149:12 151:18 153:8
166:20 169:18 170:21 181:10 184:
7 188:7 224:10,21 229:5
impacted [2] 170:14 173:1
impacts [3] 181:2 278:11 293:14impaired [1] 195:14
imperfect [1] 44:13
implementation [1] 262:8
implies [1] 255:6
importance [4] 18:5 102:3 261:2
281:7
important [79] 23:3 42:15 44:9 46:
3,4 49:8 52:7 55:4,19 56:20 59:4
61:19 62:10 64:6,13 65:1 67:7 72:
20 73:22 78:12 79:19 80:10 81:14,
17 84:5 87:18 90:13 92:7,22 95:2
Sheet 12 hear - important
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 13/28
96:15 98:15 108:11 109:4,5 122:8
134:1 138:10,15 145:4 154:22
156:11 164:1,19 165:4 167:19
170:10 172:16 184:20 193:5 195:
15 196:3,13 209:7,15 210:13 216:
13 221:16 223:15 224:22 230:16
231:19 232:18 235:5 236:13 242:
18 243:13 247:12 253:7,8 254:22
266:4 275:20 280:6 281:8 282:19
284:6 295:12 298:8
importantly[6]
52:13,18 80:2 116:4 127:22 204:21
impose [1] 281:22
impossible [2] 193:15 245:13
impression [1] 200:10
improve [6] 97:10 153:14 175:5
184:3,15 196:7
improved [3] 82:13 99:17 132:17
improvement [8] 79:19,22 82:9
99:16 125:4,6 128:20 129:15
improvements [1] 129:7
improving [1] 126:17
inadequate [3] 275:2 276:7 289:7
inadvertently [1] 283:10
inapparent [1] 47:10
incapable [1] 80:21incarcerated [3] 194:17 307:8,12
incentive [1] 93:10
incentivize [1] 271:12
incidence [3] 51:4 82:11 124:19
incident [1] 108:12
include [25] 24:16 42:7 75:16 114:
1 131:21 137:18 154:12 173:2
193:6 200:16 202:3 203:10 208:7
223:14 224:3 234:3 246:9 253:17
268:11,15 271:7 278:18 284:20
303:19 311:20
included [11] 88:8 115:21 130:7
189:10 203:12 215:19 217:10 225:
17 232:13 302:22 307:8includes [4] 88:10,11,11 263:20
including [12] 23:1 35:17 62:14
89:5 110:15 216:9 224:11 257:17
258:3 284:7 302:8 308:2
inclusion [18] 72:17 76:11 77:9,11
78:3 137:15 138:6,18 188:13,22
189:2 196:22 197:11 241:22 249:
5,6 279:13 281:14
inclusive [4] 75:17 76:6,11 203:16
incompatible [1] 224:16
incomplete [1] 72:10
incorporated [1] 134:13
incorrectly [1] 224:1
increase [8] 27:11 48:18 61:16 72:
4 211:9 231:16 248:21 303:9increased [5] 10:15 23:13 48:11
65:17 74:3
increasing [5] 60:16,18 108:17
150:16 236:4
increasingly [2] 187:10 276:2
increment [1] 71:12
IND [44] 12:16 14:9,20 15:4 106:17
107:1,13 108:7 111:13,19 113:5,6
115:13 116:12 118:5,21 119:4
120:14 121:5,7,20 122:3,9 123:1,
5,10,11 124:4 126:2,15 130:1 135:
7 136:5,10,15 137:15,16 139:15
140:7,22 154:11 194:1 198:10
260:13
Indeed [8] 56:13 58:10 73:5 135:
18 141:3 175:15 247:8 296:9
independent [4] 29:2 79:1 105:13,
14
indicate [3] 125:8 135:17 227:6
indicated [4] 108:13 117:9 234:17
268:20
indicates[2]
108:11 181:3indication [13] 11:1,4 74:13 91:12
92:3 153:22 182:13 229:1 233:7
234:14 269:15,16 271:8
indications [1] 74:12
individual [19] 19:11 20:11 24:6,19 30:16 31:10 45:9 46:8 53:7 63:
14,19 64:9 66:19 145:14 156:5
218:18,22 276:14 286:20
individual=s [1] 172:17
individualization [1] 24:14
Individually [1] 9:22
individuals [27] 45:22 67:20 69:
21 79:3 81:19 116:5 127:3 147:16
148:22 149:2,21 151:18 152:15
186:11 189:7,8,9 192:17,17 194:15 203:22 215:15 224:11 228:22
245:16 286:22 307:12
INDs [1] 12:7
induced [1] 58:5
induction [1] 281:18
industrial [1] 7:9
Industry [15] 2:10 3:23 8:12,15,16,
17 13:2 15:18 106:7,14,16 170:4
187:15 191:6 256:10
ineffective [2] 57:16 276:21
ineligible [1] 276:2
inevitable [1] 126:22
inexorably [1] 81:12
infect[1]
82:5infected [38] 11:2 21:19 22:9 23:8
27:21 28:4 30:9,11,13 32:1,7 36:
17 43:16 46:11 53:15 56:13 57:6,
8,18 58:9 63:13 64:1 73:1 81:19
82:3 108:14 112:2 161:22 162:16
170:13 181:18 182:9 184:7 187:1
199:4 228:22 272:16 287:2
Infection [59] 3:16 10:20,22 18:4
22:11,12 23:13 25:22 26:4,9,14,
15 27:5,20 28:17,20 32:4 38:3 39:
3 43:16,20 44:3,20 45:4 48:16 50:
14,20 51:9 52:8 53:14 55:8 59:7
62:11 66:9 72:2 74:4,7 78:18 80:9
83:11 99:2 108:12 109:1 180:12,
16 181:17,21 182:2,6,17 187:9,12231:10 279:11 286:13,16,19 287:
1 290:6
infections [11] 5:6 6:22 10:17 21:
7,8 22:4 51:1 58:20,21 75:21 183:
2
infectious [5] 5:2,12,14 16:14 231:
10
infectivity [1] 28:5
infects [3] 44:4 52:9,13
infer [1] 162:15
inference [1] 154:4
infiltrates [1] 68:5
inflamation [1] 75:4
inflame [1] 68:7
inflamed [2] 63:1 67:1
inflammation [7] 52:19 67:2,6 69:
10 166:18 169:2 170:17
inflammatory [5] 53:19 57:18 68:
5 170:15 196:6
inflection [1] 33:14
influence [1] 170:18
inform[4]
70:16 74:19 161:18 164:10
information [40] 8:3,6 36:4 42:7
74:17 86:21 142:21 147:13 149:
19 168:2 169:12 170:9 172:13
173:2 178:14,21 216:15 220:4,12,
14 223:16 225:21 228:4 246:19
260:12 266:4 269:19 283:19 285:
3,18 290:14 293:7,10 294:7,9,15
295:11 296:9 300:9 301:13
informative [1] 68:11
informed [3] 213:17 287:6 293:10
informing [1] 77:6
inhibit [4] 61:9 63:4 183:14 184:21
inhibition [2] 153:7 277:9
inhibitor [5] 91:15,16,20 102:15266:17
inhibitors [18] 12:8,9 85:4,13 86:5,
9 95:16,18 102:7,8,16 103:5,13,15
145:17 151:17 260:5 266:19
initial [53] 13:6 16:6 31:17 63:14
112:5 113:21 114:2 137:15 177:6
191:19 197:1,12 200:10 207:15
209:22 215:18 225:14,19 226:13
233:13 234:8 235:11 241:4,22
243:9 244:3,17,20 245:1 246:6
247:7,22 253:11 257:13 258:19
259:12,13 263:16 264:10 265:10
268:8 269:2 270:22 284:13 285:
17,19 294:9,14 296:20 297:2,3,16311:7
initially [7] 13:16 33:13 111:11,15
222:14 223:12 264:21
initiate [4] 215:14 228:6 232:20
268:9
initiated [6] 174:5 177:18 232:22
254:17 259:12 270:10
initiation [6] 179:14 228:3 243:5
262:2 301:18 305:15
injectable [2] 253:17 254:10
injected [1] 23:14
injection [1] 99:1
innate [3] 60:7,11 72:12
input [7] 10:7 118:3 121:14 129:12
133:4 185:13 197:3inquired [2] 12:18 13:20
insert [1] 294:9
insights [1] 154:10
insisted [1] 89:20
insistent [1] 131:20
insofar [1] 159:9
instance [4] 120:6 253:6 289:17
307:7
instances [3] 120:12 140:4 231:
11
Instead [3] 29:3 97:11 166:21
Institutes [1] 5:18
institutions [3] 7:10,13 194:19
instructions [1] 8:1
instructive [2] 61:8 181:15
insufficient [1] 269:16
Insurance [1] 234:12
integrate [1] 158:19
intended [1] 297:20
intent [1] 254:17
intention-to-treat [2] 249:17 275:
7interaction [16] 91:8 133:17,19
230:5 233:3 260:16 261:1,3,7,13
262:15 264:7 277:2,16 303:5,12
interactions [14] 187:21 212:13
224:18 227:20 259:6,6,18 260:4
265:1,20 268:11 277:10 303:4
312:14
interactive [1] 4:10
Interest [12] 3:5 6:12,13,15 7:15 8:
9 9:1,4,8 168:6 172:4 191:9
interested [4] 140:8 173:15 176:5
196:13
interesting [5] 169:16,19 176:15
178:8 249:8
Interestingly [1] 127:22interests [2] 7:11 8:17
interfere [2] 62:9,12
interferon [89] 11:9,13 13:22 14:
18 29:21 30:21 34:14 36:6,9 38:
17 42:1,2 51:11 58:3,6 59:11,12,
21 61:5,21 71:8 72:15 80:22 81:
15 91:22,22 100:12,16,18,20,22
101:4 112:16 115:22 116:10 117:
6 118:2,9 122:16 123:20 125:1
131:11,13 135:10 139:16,21 141:
1,3,5,6 148:5,8,8,9,10 149:1,4,10
151:7 159:9 163:8 175:6,14 176:8,
13,17 179:17 191:13 192:2 193:7,
8 196:1 231:3 247:9 254:1,4,10255:8,13,16 256:1,11,21 287:16
289:6 290:15 291:1,10 292:9
interferon-alpha [6] 59:4,9 60:5,
10,22 61:9
interferon-based [31] 21:4 29:4
37:3 63:10 72:13 109:8 113:1 114:
16 117:17 122:11,12 123:22 131:
5 134:18 135:16 139:13 141:10
150:7 156:18 158:14 159:8,15
161:2 162:19,19 179:8 183:10
192:1 195:21 196:9 221:2
interferon-containing [1] 115:21
interferon-free [1] 124:12
interferon-gamma [2] 60:15 62:
21interferon-regulated [1] 59:14
interferon-resistant [1] 193:10
interferon-ribavirin [10] 91:21
130:3 151:8 208:1 233:11,14 234:
4 235:3 287:20 290:13
interferon-treated [1] 61:12
interferon=s [2] 62:4 139:20
interferons [4] 12:9 73:15 112:13
127:12
interim [1] 167:7
intermediate [1] 262:19
Sheet 13 important - intermediate
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 14/28
intermittently [2] 53:21 137:9
internal [2] 18:18 98:1international [1] 247:17internet [2] 86:11,16
interpose [1] 70:17
interpretability [1] 134:15
interpretable [2] 138:3 139:3
interpretation [3] 107:21 155:14,
16
interrupt [1] 202:12
intervals[1]
193:2intervenes [1] 29:19
intervenesB-interferon [1] 29:
20
intervention [2] 38:7 55:22
interventional [1] 67:16intolerability [1] 11:19
intolerance [3] 125:1 174:21 175:
3
intranasal [1] 24:17introduce [3] 16:1,7 27:14
introduced [1] 153:10
introduces [1] 38:9
introducing [1] 206:8
introduction [6] 4:17 107:18,19
108:9 156:17 180:5introductions [1] 16:6
Introductory [3] 3:7 9:11,13
Intron-A [1] 174:5
intrude [1] 117:6
intuition [1] 136:18
inverted [1] 308:10
investigational [15] 14:11,19,2294:5,11 97:5 129:21 130:16 131:2,
15 133:6,21 179:15 214:17 247:2
investigator [1] 114:13
Investigators [1] 178:20
invited [2] 8:12 85:8
inviting [1] 83:21
involve[4]
7:9 8:20 161:20 203:1involved [14] 18:21 34:10 35:20
94:18 147:11 151:2 177:1 201:9,
10 220:20 289:16 291:20 292:8
293:3
involvement [2] 9:1,5
involves [1] 31:14
involving [2] 56:15 71:17
ionosine [1] 62:9
Ireland [1] 46:10
IRES [1] 18:19
ironed [1] 94:3
Ischak [1] 125:6
isn=t [4] 136:21 160:11 234:11
302:13
isolated [2] 19:14 20:21issue [75] 6:15 28:9 37:5 49:8 64:
10 66:17 71:4 76:22 79:9 112:12
121:15 143:12,18 144:7 145:6
150:2,7,12 156:11 161:10 162:1
164:2 167:10,13 173:9 192:9 193:
17,21,22 197:8,14 199:7,12,17
201:11 214:4,6 223:7 226:9 241:
19 244:5,10 245:21 246:12 249:9
251:13,17 258:2,11 267:8 271:19
272:9 273:14,16 274:2,5,13,14
275:14,20 276:10 284:17 298:15
299:1,2,7 301:1,22 303:4,5 308:
11 309:1,3 310:16,19
issued [1] 23:12
Issues [66] 3:9 4:5 6:21 7:2,6,7 9:
12,14 10:9,11 11:17,19 12:15,17,
21 17:13 42:18 49:11 50:9 54:6
61:20 70:8 74:18 79:11 80:17 84:
7 87:12 90:1,2 96:8 98:14 109:12
118:3 125:21 143:16 145:8 146:
12 156:11 158:12 181:5 186:1,7
188:5,7,9 189:7,8,17 190:11 193:7 195:18 202:18 212:13,21 217:1
225:10 233:3 234:21 235:1 252:4
258:9 274:1 298:4 309:1,7 311:22
itB-do [1] 254:7
itself [7] 27:21 29:1 57:14 122:6
132:12 255:15 275:12
IUs [2] 123:8,11
IUs/ml [2] 69:6 120:21
IV [3] 230:11 232:20 270:13
JJak [1] 59:12
Jan [2] 220:7,10
Janet [5] 2:5 5:19 7:19 272:15 302:
7Janice [3] 3:28 173:19 174:1
Japan [1] 168:14
Jay [1] 198:12
Jeff [1] 151:5
Joe [1] 25:17
John [16] 2:20 3:16 6:2 7:20 15:15
50:7 71:3 151:12 196:6 210:4 220:
17 273:15,21 281:13,15,21
joining [1] 180:12
journal [2] 86:18 153:20judiciously [1] 107:12
Jules [5] 3:20 15:16 83:16,17 230:
9
July [1] 23:19
jump [3] 171:8 238:2 289:2
jumping [1] 102:14
jumps [1] 17:19
jury [1] 299:19
justB-I [1] 214:14
justification [1] 154:18
KKaren [6] 2:15 3:31 4:19,20 7:19
190:17
Katherine [1] 2:23
Katie [1] 6:7
keep [11] 17:7 28:8 47:16 59:20 95:
20 102:19 126:2 170:10 193:10
199:3246:
2
keeping [1] 77:12
Ken [7] 15:12 16:1 84:6 159:20
162:6 191:2 240:2
Kenneth [4] 2:2 3:3,13 7:20
Kessler [1] 85:14
key [5] 25:15 54:5 94:4 280:15 284:
16
kibosh [1] 210:18
kid [1] 298:17
kids [6] 294:17 296:4 298:14 299:7,
20 301:15
kill [1] 197:21
killer [2] 60:7 181:20
kilo [2] 299:9,10
kind [13] 34:12 43:1 150:2 151:1
166:13 175:3 195:19 207:20 230:
20 235:22 241:5,6 277:11
kinds [5] 164:13 179:19,19 185:18
218:14
kinetic [13] 31:18 32:22 35:10,14
39:18,21 40:7 41:9 42:17 59:16
159:20 243:3 285:1
Kinetics[21]
3:12 15:14 16:3,2228:10 35:7 58:1 134:22 164:8,11
169:9 181:13 183:5 184:13 222:2
223:16 228:5 265:1,18 282:14
288:10
king [1] 120:17
Knodell [1] 125:5knot [1] 56:2
knowing [2] 54:3 78:7
knowledge [4] 83:9 137:19 158:
15 275:3
knowledgeable [1] 62:2
known [4] 77:14 170:19 178:13
245:8
knows [2] 109:8 120:8
Kong [1] 129:5
LL-aminotransferase [1] 53:17
label [2] 138:9 294:10
labeling [1] 271:7
Laboratories [2] 6:1 8:19
lack [6] 79:15 108:20 124:22 125:
20 192:7 264:6
lacking [1] 189:9
lacks [1] 19:8
ladies [1] 173:22
Laessig [3] 2:23 6:7,7
lag [2] 26:5 212:13
laid [1] 261:21
language [5] 84:21 89:5,7,8,10
languishing [2] 89:4 96:20
large [22] 27:9 46:11 66:7 67:11,12,
14 76:7 94:1 135:22 178:17 191:
17 195:21 220:16 221:21 222:9
265:5 266:8 274:18 287:21 291:
15 300:5 305:5
large-scale [1] 228:3
largely [6] 20:4 32:4 57:6 74:15
148:19 153:18
larger [6] 67:19 96:11 146:21 177:
16 225:11 259:12
largest [5] 69:19 144:13 229:1 230:
8 264:16
Larry [1] 66:7last [9] 22:16 81:10 88:14 139:16
141:9 189:2 211:5 269:5 301:20
Lastly [11] 111:2 112:18 115:8 116:
3 120:13 124:8 125:8,16 131:4
133:6 135:2
late [1] 162:15
latency [1] 108:19
later [23] 25:3 38:3 50:1 57:2 71:
13 120:3 121:9 139:17 144:12
155:6 157:7,19 163:20 164:11
187:16 208:10,18 212:9 234:22
241:18 242:1 299:5 311:21
lateral [2] 56:16,18latest [1] 86:19
Latinos [3] 75:18 98:11,16
latter [1] 51:22
laudatory [1] 276:20
Laughter [8] 146:17 198:19 238:1
272:8 295:5,10 299:21 305:8
launch [1] 272:4
launched [2] 89:1 197:17
law [1] 171:19
layers[1]
171:2lead [11] 47:20 161:5 185:10,17
186:5 224:17 233:7 270:20 288:
17 295:17 309:9
lead-in [1] 240:18
leading [12] 21:12 52:19 55:11 57:
16 81:7 86:10 97:18,22 98:3 99:2
114:11 152:14
leads [13] 19:9,16 31:1,13,22 33:
14 37:15 44:5 49:14 57:9 70:15
72:6 81:10
leap [1] 242:12
learn [5] 37:9 104:10 222:20 241:
19 256:20
learned [3] 51:10 190:5 211:8
learning [1] 109:3least [47] 16:21 21:6,7 40:8,10 54:
1 66:2 71:7 94:18 114:10 115:17
116:9 127:18,20 128:2 132:9 136:
13 145:20 206:2,6 216:12 222:5,
11 226:22 227:3,18 232:6 242:19
245:11 261:14 262:20 268:9,18
269:15 291:1,14 292:1 293:2 297:
5,20 301:18 303:19 304:13,19
307:21 308:1 310:17
leave [2] 49:19 64:14
leaving [1] 77:15
led [1] 70:2
leeway [2] 210:15,22
left[8]
30:8 31:21 44:3 54:13 56:762:20 83:8 110:5
legitimate [1] 274:9
length [2] 21:2 166:15
Leonard [4] 2:18 5:17 202:12 223:
22
less [34] 29:5 37:7 38:2 39:1 44:2
62:1 65:16 68:14 117:22 120:9,9,
20 123:16 129:3 136:3 146:7 150:
18 151:17 165:12 170:14 172:6
174:21 187:13 190:1 203:12 212:
6 214:1 219:1,2,6 244:8 286:13
298:14 310:16
lesser [4] 194:7 218:1 286:2 292:
21
lesson [1] 190:8lessons [1] 51:9
Let=s [13] 4:18 63:9 91:16 95:13
102:19 106:4,6 136:12 209:3 253:
16 254:2,4 258:17
lethal [1] 127:14level [8] 27:8 33:11,13 95:10 165:10 251:5 277:15,22
levels [14] 19:5 33:17 42:8 58:4 61:
16 127:5 140:6 165:8 260:6,7 277:
8,13 278:12,13
Levin [5] 3:20 15:16 83:16,21 230:
Sheet 14 intermittently - Levin
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 15/28
9
Liauw [1] 153:19
licensed [2] 178:4 207:6
licensing [1] 262:7
lie [1] 187:6
life [7] 54:22 55:3 82:13 250:4 252:
4 276:7 293:18
life-saving [1] 213:21
life-threatening [1] 261:2
lifestyles [1] 189:5
lifetime[1]
93:17light [1] 100:19
likelihood [8] 49:12 149:15,22
152:18,20 195:11 238:15 262:5
likely [32] 11:5 29:5 39:1,7 65:16
108:22 117:20,22 125:2 134:5
136:2 141:1 143:12 165:10,12
170:1 173:1 184:6 185:8 192:2
219:11 220:5 221:22 227:7 231:
20 235:8 249:21 257:19 262:9
268:17 286:15 306:20
Likewise [1] 173:5
limit [2] 63:12 292:8
limited [10] 11:18 23:4 72:2 101:
15,16,16 135:2 141:4 206:14 210:
5limiting [1] 172:5
Lindsay [4] 3:31 190:17,19 204:21
line [4] 34:19 101:7 110:12 211:15
lipids [6] 104:17,19,22 105:1,2,3
liquid [1] 291:5
Lisa [1] 74:10
list [16] 75:7 76:15 79:4 142:7 153:
13,16 199:22 205:8 210:3 216:20
217:12 228:14,14,17 276:4 312:9
listed [5] 78:21 204:2 217:1 218:1
274:3
listened [1] 264:13
listening [1] 106:2
listing[1]
210:8literally [1] 297:13
literature [9] 40:4 58:8 126:14,16
129:5,16 135:16 164:21 165:18
little [37] 22:17 28:12 35:22 38:21
47:2,3 84:11 98:9,20 100:4 101:2
131:14,14 156:10 158:18 163:11
169:3 178:14 207:20 208:2 210:
15,22 211:17 216:4 218:8 219:12
242:11 243:6 245:4 262:18 277:
21 294:7,8 300:18 301:21 307:9,
11
liver [93] 5:17 6:3 11:1 13:13 17:16,
21 18:2,12 21:12 22:6 23:20 25:
20 26:11,12 28:1 45:10,13,15 46:
22 47:4,5,18,20 48:3 54:5 55:1561:17 62:20 66:17 68:7,8 71:15
73:8 75:2 101:14 105:3 108:16
109:4 110:9,13,19 111:22 113:22
119:19 120:2 124:20 126:3,6 127:
4,6,10,14 128:16,19,20 134:16
136:3 137:17 143:11 144:5 152:9,
16,19 160:20 187:9 195:5,5,13
199:16 203:2 212:6 213:15 215:8
219:20 221:11 222:20 223:8,9
228:4,6 230:7 231:14 232:1 273:6,
20 276:7 284:18 285:10 286:14
293:5,13 296:3 298:20
liver-related [1] 48:13
livers [1] 61:11
lives [2] 261:7,11
living [5] 84:14 145:3 152:8 260:
18 293:16
load [30] 27:1,2,11 28:21 29:1 30:5,
10 31:18 33:5,10,20 37:6 41:19
43:14 63:13 69:4,18 113:10 127:4
135:22 140:11 162:11 163:16 165:
14 166:22 169:21 183:10,22 184:13 267:12
loads [6] 28:13,15 29:5 69:6 267:6
282:13
lobule [1] 47:4
localized [1] 60:15
lodging [1] 173:4
log [7] 27:3,5 37:8 116:2 129:14
236:3 238:19
logical [1] 212:3
long [25] 12:22 33:18 37:19 41:12
63:21 64:11 68:9 77:21 80:3 96:
20 103:17 106:1 108:19 142:7,10
144:21 163:1,12 214:20 228:12
239:3 246:22 264:3 288:4 293:15
long-term [23] 7:4 24:10 49:16 61:20 80:6,7 82:12 104:7,9 105:6
135:14 137:1,7 141:19 149:8,12
162:14 163:3 167:10 169:4 175:
16 184:5 244:7
longer [16] 20:12 28:6 45:8 68:15
73:17 82:4 119:2,10,16 133:15
136:19 141:15 157:16 192:20 217:
13 249:22
look [54] 17:15 27:4 33:2 36:4,8,16
39:22 46:21 50:18 51:10,16 54:19
59:16 64:6,20 66:17 69:5 73:13
74:10 79:5,11 90:3 93:15,19,22
111:21 143:22 145:7,20 148:18
149:18 157:19 168:2 174:20 181:15 182:13 233:1,2,17 236:20,20
240:11 241:10 243:3 260:3 277:
20 280:3 304:2 305:18 307:22
309:7 311:8 312:9,13
looked [4] 27:1 149:2 254:19 286:
10
looking [30] 22:21 33:16 39:17 45:
21 46:10 49:11 59:5 79:2 102:5
113:3 115:17 137:8 143:7 146:3
151:15 152:6,21 168:8 171:3 184:
8 193:6 205:18 211:16 213:5 238:
4,12 246:18 264:22 273:3 275:16
looks [8] 53:18 57:22 61:20 73:6
91:17 227:18 271:17 280:1
Los [1] 86:7lose [1] 175:22
losing [1] 199:3
loss [5] 25:7 30:16 42:8 175:15
237:13
lot [31] 29:11 39:15 84:7 90:19 93:
11,12 94:9 95:11 98:17 104:10
131:19 178:1 192:20 196:7 213:
20 218:9 226:9 227:14 238:5 240:
14,22 263:11 266:18 267:16 278:
14 289:22 298:12 309:14,15 310:
2,3
lots [1] 104:11
loved [1] 121:2
low [18] 23:7 24:7,12 69:5 135:5
149:22 150:15 204:12 238:9,18
271:22 275:8 278:22 280:4 282:
11,12,13 309:4
lower [21] 14:17 33:13 63:12 72:7
104:18 112:22 123:9 131:11,14
146:8 169:20 194:16 195:11 255:
6 266:3 275:16 300:17,18 301:11
302:20 303:6lowering [1] 300:13
lowest [1] 111:17
LSU [1] 5:7
lucky [1] 280:10
lunch [3] 142:6 171:10,12
lymphocyte [1] 55:12
lymphocytes [3] 18:13 52:10 55:
20
MM.D [21] 2:2,6,7,8,10,12,15,16,18,
20,22,23,24 3:3,9,13,16,24,28,29,
31
made [22] 6:16 24:20 48:10 53:4
90:20 95:11,12 98:2 102:14 155:7,13 156:2 157:15 184:20 192:16
214:19 218:7 224:1 239:19 268:9
288:15 292:20
magnitude [1] 182:4
main [7] 25:1 29:3 39:9 90:18,21
108:2 302:22
mainly [1] 194:12
maintain [2] 260:5 282:16
maintains [1] 260:7
maintenance [2] 167:4 281:18
major [16] 67:10 75:1 76:12 87:3,4
88:19 119:1 135:4 241:7,9 245:11
268:11 303:19,22 307:16 309:3
majority [5] 107:6 194:9 298:19
304:16 311:10
make?@ [1] 37:8
makeB-because [1] 90:19
malignant [1] 51:5
managed [1] 168:3
management [3] 23:22 163:6 203:
19
mandate [2] 243:16 293:2
mandated [2] 273:5 284:12
mandating [1] 299:1
manifest [1] 45:13
manifestations [2] 51:2 80:1
manipulating [1] 131:13
manner [4] 18:3 81:6 205:21 282:
4manufacturers [2] 85:8 254:3
many [47] 7:9,13 20:1 22:12 44:9,
14 46:1 61:13 67:15 73:7 75:15
76:13 77:3,10,13 88:16 89:16,16
90:2,2 99:1 105:5 111:8 143:14
150:19,21 152:10 172:8 179:1
189:5 197:4 210:2 215:7 219:13
234:1 242:19 247:2 251:2 261:5
274:22 276:3 289:19 295:2,7,7
299:15 306:2
March [3] 86:4 106:17 126:5
marches [2] 120:8 135:18
marginalized [2] 98:22 99:1
mark [1] 40:16
marker [2] 29:2 53:19
markers [2] 61:15 181:14
market [18] 11:10 90:13,15 91:7,
10 92:5 93:6 94:17 98:7 100:2
103:6 105:19 155:3 199:20 200:8
207:3 242:7 299:4
marketB-I [1] 207:2marketing [8] 13:8,14 215:18,19,
22 248:15 264:10 285:17marrow [2] 127:13 150:12
marvelous [1] 231:6
Maryland [2] 1:10,11
mass [1] 161:22
Massachusetts [1] 16:9
master [2] 19:15 25:15
matched [2] 35:5 36:9
maternal [1] 112:3math [3] 29:11 31:1 286:5
mathematical [4] 19:21 29:9 31:
14 41:17
mathematics [1] 35:19
matter [4] 151:10 161:3 186:2 252:
6
matters [1] 7:17maximum [2] 172:5 299:17
maxing [1] 217:2
McHutchinson [1] 71:4
mean [32] 33:3 91:13 104:4,5 112:
7 117:13 128:8 165:17 177:17
200:21 213:19 221:11 223:7 231:
13 236:17 245:17 247:11,13 251:
19 282:12 283:15,20 294:10 297:
14 298:13 303:17 304:2,11 308:8
309:16,18 312:7
meaning [5] 30:13 44:3 197:8 227:
11 302:10
meaningful [4] 140:6,10 163:21
238:21means [8] 77:7 122:13 155:10 211:
18 214:16 227:13 307:9 308:14
meant [1] 17:2
measure [4] 53:18 79:20 164:3,7
measured [2] 121:16 156:21
measurement [3] 25:13 35:18
121:18
measurements [1] 183:11
measuring [3] 27:2 147:3 253:15
mechanism [5] 32:6 132:6 181:11
183:13 185:9
mechanisms [11] 27:17 32:9 51:
11 57:22 59:3,19 62:3 72:10 133:
10,22 192:8
median [1] 26:6mediated [3] 52:16,22 60:18
Medical [17] 3:19,24 5:2,7,15 6:5
10:2 16:15 24:8 49:5 86:21 179:
22 180:7 198:4 217:17 219:4 300:
8
medication [1] 292:13
medications [3] 290:18 291:1
312:14
Medicine [5] 3:17 5:15 6:3 98:1
192:12
medicines [2] 189:20,22
Sheet 15 Levin - medicines
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 16/28
meet [5] 103:8 111:4 175:13 215:7
291:22
meeting [18] 4:3,12 6:17,18 7:9,21
8:3,14 12:13,15 15:11,12 17:12
50:5 172:15 173:1,5 312:3
meets [1] 6:20
MEL [1] 151:12
MELD [15] 79:20 128:17 129:8 140:
7,11 145:21 146:7,8 204:9,11 225:
6 278:22 279:2,6 280:4
member[3]
7:15 62:15 186:18MEMBERS [10] 2:4 4:6,18 7:10 9:
17 16:5 114:8 142:11 197:4 288:2
membership [1] 105:16
men [4] 38:18 188:14 201:14 308:
20
mental [2] 189:8 293:16mention [8] 84:8 88:14 95:15 100:
4 101:12 188:10 293:18 312:10
mentioned [21] 21:6,11 72:19 88:
1 98:17 99:12 100:6 103:2 115:5
135:11 145:6,19 160:11 174:11
178:10 181:22 191:2 195:19 210:
4 280:18 312:12
messes [1] 35:19
met [2] 87:3 150:17metabolic [2] 51:4 188:11
metabolics [1] 104:12
metabolism [6] 133:18 219:5,10
233:1,4 277:10
metabolized [2] 170:19 227:15
metallo-matrix [1] 61:18
methadone [1] 99:4
method [1] 29:20
methods [1] 25:11
Mexican [2] 304:11,19
mg [3] 255:22 301:3,5
mid [1] 174:7
middle [7] 59:10 158:21 212:16
304:3,3 309:10,22might [62] 20:10 37:7 58:16 85:22
100:16 101:1 103:8 107:3,8 114:
22 119:11,17,21 128:14 130:13
132:16 133:17,19 134:17,19,19
142:21 143:5 144:14 153:6,22
154:4 162:6 163:17 166:19 169:
18 178:12 181:2 185:14 192:21
204:11 206:10 208:2,5 209:5 212:
17 214:13 221:11 222:7 229:13,
15,17 238:7,20 241:5 242:15 243:
6 249:13 266:16 267:10 269:12
279:17 284:9,11 290:10,10 295:
17
Mike [1] 40:15
mikes [1] 4:7milder [1] 112:3
mildly [1] 127:19
miles@ [1] 83:8
milieu [3] 56:3 63:5 170:15
military [1] 23:1
million [10] 10:19 11:2 21:7,8 22:8,
13 23:8,8 108:10,10
Milwaukee [1] 5:3
mind [20] 17:8 47:17 59:20 74:17
82:15 94:10 95:20 102:20 143:16
170:10 182:22 206:4,18 214:6
223:22 224:20 232:1 246:2 290:8
309:13
minds [1] 136:14
mine [1] 116:17
minimal [5] 147:21 166:14,15 231:
18 290:20
minimally [1] 151:11
minimize [4] 46:15 134:20 276:18,
20
minimizing [1] 298:20
minimum[4]
168:15,16 177:7 261:12
minor [2] 33:7 34:4
Minorities [1] 137:18
minority [1] 201:3
minus [2] 29:14 31:6
minutes [5] 92:18 172:1,5 186:12
203:8
Miriam [9] 2:14 16:13 49:21 146:
13 147:10 216:19 223:7 306:8,14
mirrored [1] 48:18
Miss [2] 259:5 290:18
missing [2] 43:3 290:19
mistake [3] 102:13 126:4 223:3
mistakes [4] 95:11,13,14 102:4
misunderstand [1] 294:3misunderstanding [1] 157:3
misunderstood [1] 205:6
mitigated [1] 8:11
mix [1] 281:19
mixed [3] 185:15,18 304:10
mobilizing [1] 185:1
modality [2] 185:15,18
model [18] 34:20 35:2,13,16 36:142:11 43:4 49:14 90:4,22 94:12
95:3 125:11 128:16 165:2,6 242:
11 290:3
Modeling [17] 19:5 29:6 31:14 32:
22 36:3 37:9 38:6 39:21 41:9,16,
17 42:4,17 81:21 161:18 166:1170:8
models [21] 34:17 35:20 39:19 42:
7,12 43:6 44:1,8,13 59:8 60:17
160:22 164:14,18,20,22 166:5
184:8,10 275:10 290:13
modifiable [2] 43:18 46:8
modification [1] 278:16
modified [1] 255:19
modifier [3] 46:3,4,5
modifiers [1] 46:2
modulators [1] 29:21
molecule [4] 29:22 221:3 241:13
242:3
molecules [4] 12:8 160:18 240:3
247:9moment [4] 112:19 147:1 191:7
271:16
momentB-and [1] 221:10
moments [1] 112:8
money [1] 214:7
moninfection [1] 88:3
monitor [2] 179:10 278:13
monitored [1] 141:21
monitoring [3] 211:9 277:8 308:
14
mono-infected [3] 35:5 91:19
272:20
mono-infection [15] 87:14,16,21,
22 88:10 91:13 99:21,22 100:7
187:19 261:22 262:4,13 271:15
310:12
mono-specific [1] 60:3
monophosphate [2] 62:8,10
monotherapy [28] 14:14 15:1 58:
3 61:13 64:10 80:22 103:11,16
118:19 119:12,16 130:9,13 132:
21 135:3,10 140:17 141:4,7 148:8,9 163:12,15 190:3 209:6 236:2
240:21 282:21
monotherapyB-agreement [1]
135:2
month [2] 71:14 166:10
months [6] 26:15 37:11 110:10
119:3 175:18 252:20
moot [1] 231:12
more.@ [1] 136:7
morning [22] 9:15 10:10 29:11
106:9,10 111:9 142:3,12 174:9,12
175:7 177:14 178:2,7 190:4,20
191:16 193:22 198:9 233:21 237:
22 312:22
mortality [7] 48:13,17,18,22 74:379:21 151:6
most [59] 10:22 20:18,20 21:18 22:
19 27:1 30:19 31:21 43:15 47:9
64:22 70:14 71:21 75:20 76:19 77:
19 78:12 90:9 98:21 99:5 109:3
113:13 118:8 120:19 125:2 134:5
138:2,3 143:12,13 146:12 154:16
166:11 175:10 189:13 192:11 204:
21 205:17,17,20 207:4 210:1 211:
22 216:10 219:13 222:7 232:17
235:21 272:1,3 283:7 286:15 292:
10,21 293:4 297:17 298:15 304:
22 306:19
mostly[2]
126:13 310:12mother [2] 109:2 287:2
mothers [1] 24:2
motivated [2] 287:7 293:9
move [19] 17:13 50:10 90:1 96:2,3,
10 99:7 100:14 101:18 105:15
108:4 122:12 163:21 176:20 200:
9 209:4 264:8 266:11 305:20
moved [1] 80:15
moving [12] 21:17 81:11 110:12
118:5 122:19 126:1 131:10 137:
14 146:7 176:21 199:15 229:2
mRNA [1] 61:10
MS [11] 5:4 197:16 211:13 212:2
234:10 240:10 260:15 266:7 271:
11 305:17 312:7much [58] 10:3,7 15:22 17:10 31:
15 32:12 36:11 37:8 38:3 41:19
45:3 50:15 58:7 67:18 83:14 86:
15 88:18 103:20 105:22 118:16
126:3,14 127:9 142:4 160:12 177:
1 180:1 194:21,21 198:2 201:9
202:5 209:6 235:8 237:11 242:12
252:2,4 258:9 264:7 271:3,20 275:
19 277:19 279:2 281:1 285:18
289:13 290:16,22 298:18 299:15
301:5,8 304:13 311:15,17 312:21
multi-drug [1] 134:7
multi-investigational [2] 96:13
105:18
multi-phase [1] 164:18
multi-specificity [1] 59:21
multiple [16] 18:11 19:12 24:10,22
34:15 94:5,11 97:4 100:14 121:13
179:15 214:21 246:20 257:15 275:
17 276:15
multispecific [1] 55:14
Munk[5]
2:9 16:11,11 229:21 268:2
Murray [18] 2:15 4:19,20,20 7:19
154:8 272:6 285:12,15 289:12
291:14,20 292:7,16,19 294:18
295:1 299:18
must [6] 58:22 188:8,16,18,19 209:
21
mutagenic [1] 62:15
mutation [1] 235:1
mutational [2] 179:20 235:7mutations [1] 170:1
mutually [3] 56:6,9,14
mycophenolic [1] 277:20
myself [4] 52:2 84:12 126:2 286:6
mysterious [1] 117:12
Nnaive [36] 13:7 14:4 56:1 118:6
139:7,8 140:16 143:8 201:21 202:
1 206:9 210:18 211:9,10 217:21
233:11,13,22 234:7 235:9 237:5
238:5 240:7 244:2 246:17 259:13,
16 262:2,3 263:15 264:5 272:12
275:11 280:19 283:6 285:9
naive-treated [1] 143:1
naivete [1] 283:4
name [4] 173:13 174:1 180:6 186:
16
Namely [2] 12:18 149:3
narrow [4] 182:11 247:4 296:21
297:1
NATAP [6] 3:22 83:18 84:13 86:5,
10,12
National [4] 3:22 5:18 74:10 83:18Natural [13] 3:11 15:13 16:2,19 44:19 58:11 60:6 74:6 82:3 194:10,
22 204:5 242:21
naturally [1] 181:16
nature [9] 8:10 22:18 87:19,20 99:
19 154:15 257:11 274:15,16
NDA [1] 180:15
near [4] 163:5 176:7 218:4 225:9
near-term [1] 185:10
nearly [1] 72:7neat [1] 234:1
necessarily [17] 58:13 59:22 92:3
105:13,14 206:12 211:10 233:6
236:17 256:18 257:14 260:9 284:
12 291:9 293:8 300:21 303:9
necessary [6] 62:11 141:11 165:
14 230:2 304:12 311:21
necessity [2] 41:14 260:8
necroinflammatory [1] 203:16
need [137] 4:7 11:3 13:14 23:22 24:
5 44:12 47:16 50:10 67:14 68:2
72:15 81:15 88:6 90:3,16,22 91:2
Sheet 16 meet - need
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 17/28
93:10 95:20,22 96:2,6,9,18 98:5
99:6,8 100:1,18,21 101:2,17 102:
8,20 104:7,8,9 105:5,12 111:10
113:17,21 114:12 122:13 124:4
126:19 133:12 136:7 138:6,9 141:
15 142:13 146:9 156:12 157:18
166:3,4 174:19 176:19 177:7 179:
10,16,22 184:2,13 187:21 188:6
190:7 192:3 197:3 198:2 199:18
200:3,15 201:8,14 202:3,7 203:3,
11 210:1,21 212:11 214:18 215:7,19,20 217:5 220:4,9,11,16 229:11
230:14 234:3 237:19 238:22 239:
13 242:3 243:1,10,16 246:19 247:
13 248:10 249:22 258:12 260:2,
18 261:11 266:10 267:2 268:22
280:8 284:1 285:5,7 289:1 294:15
295:15 296:12,19,21 299:11,16
301:3,5,8 303:9,14 305:18 309:19,
20 310:4 312:1,13,18
needed [5] 109:18 206:16 232:10
256:21 263:3
needing [1] 291:5
needles [2] 67:14,17
needless [1] 138:14
needs [16] 54:20 69:22 80:7 94:296:4,16 120:7 139:12 195:15 199:
17 201:17 225:17 232:16 246:18
308:16 309:1
negative [13] 26:10 35:11,11,11
40:15,18 70:14 123:18 147:2 175:
19 181:10 243:4 265:11
negativity [2] 70:9,11
neighboring [1] 82:5
neighbors [1] 20:5
net [2] 210:7 274:5
never [3] 95:8 240:7 276:4
New [77] 5:5,16 10:17 11:4 22:4 31:
6 32:4 43:10 50:4 51:14,17,19,20
55:22 57:17 64:22 72:16 75:8 77:8,13,15 80:12 81:13 82:16,20 83:
9 86:1,6 87:9 89:16,20 94:14 95:3
98:4 102:4 103:3,7 109:17 117:7
118:16 133:2 138:16 143:8 153:
20 158:11 160:20 169:9 174:18
175:8,12 176:9 177:3 179:6 187:3
189:22 191:14 194:4 206:21 210:
12,14 217:19 218:19 221:3 242:2
247:9 250:11,16 256:12,15,22
266:15 276:16 290:3 291:3 303:7,
12 304:2
newer [4] 117:9 140:2 157:4 285:
20
newest [1] 54:17
news [6] 86:19 89:15 90:6 108:12,14 109:18
next [24] 10:10 37:12 48:22 50:7,
18 83:16 95:9 149:17 158:1 168:1
180:3 190:16 191:10 203:8,14
216:6 233:10 238:3 244:19 256:
17 258:2 274:19 285:11 287:22
NHANES [2] 22:19,22
NIAID [1] 198:13
nice [2] 58:15 304:18
nice.@ [1] 125:14
nicely [1] 84:6
NIDDK [5] 5:18 71:21 147:11 152:
7 198:13
NIH [7] 105:14 191:6 198:10,16,16
202:1 220:19
NIH/Roche [3] 291:17,21 292:7
Nile [1] 20:19
nine [2] 20:1 291:7
NK [1] 60:14
Nobody [1] 125:13
nodding [1] 272:6
nodular[1]
66:22non-A/non-B [1] 191:5
non-alcoholic [1] 46:12
non-C [1] 74:12
non-fibrotic [1] 69:9
non-Hispanic [7] 21:21 71:20 72:
6 304:6,7,14,14
non-immunosuppressed [1] 46:
12
non-inferior [2] 132:17 253:18
non-inferiority [12] 79:10 248:18
249:9,12 251:14 252:6,13,16,19
256:13 257:2,18
non-injecting [1] 24:18
non-interferon-based [3] 122:14
124:2 136:9non-invasive [3] 101:15,19,21
non-nucleosides [1] 260:4
non-pegylated-interferon [1]
254:21
non-placebo [1] 150:3
non-responder [15] 115:18,19
116:15 117:21,22 124:22 134:14
138:14 143:19 178:18 235:3,17
236:18 237:4 239:12
non-responders [34] 65:5 75:10
76:5 113:18 115:14,15 116:6,19
125:17 134:7 139:2 140:21 141:3
148:2 149:8 166:15 168:18 178:9,
11,14 179:7 190:11 193:12 194:2200:11,12 201:18 235:20 236:20
237:8 239:20 240:15 243:2 287:
17
non-response [8] 40:1 42:19 64:
20 66:2 68:22 69:20,22 70:3
non-responses [1] 307:21
non-responsive [3] 70:2,5 308:9
non-structural [2] 55:10 61:2Non-Voting [3] 2:10,19 8:15
none [3] 122:3 128:1 167:6
noon [1] 171:11
normal [7] 26:11,15 32:10 47:1110:21 111:1 162:2
normalization [1] 125:7
North [2] 66:9,14Northwest [1] 286:7
note [2] 23:3 56:20
noted [3] 9:2 125:17 187:7
notice [4] 16:4 107:10 116:16 182:
3
notorious [1] 266:21
notoriously [1] 281:20
novel [25] 117:7 119:12,16 124:8,11 130:19 131:22 132:13,20 133:
12,21,22 134:9 138:16 140:20,22
141:13 152:22 159:18 160:13 180:
21 181:10 239:6 255:14 282:3
nucleocide [1] 151:16
nucleocide/nucleotide [1] 153:
11
nucleotide [1] 18:17
null [6] 116:20 238:13 239:6,20240:16 307:20
number [37] 14:8 17:17,19 25:17
26:20 39:10 41:20 49:14 66:7 67:
12 69:1 76:7 102:7,8 125:13 130:
22 142:15 152:3 168:8 172:6 174:8 186:21 188:4,5 189:11 190:3
212:18 217:2 220:16 245:16,20
258:9 268:13 286:13 290:11,11
302:11
Numbers [6] 19:7 35:12 41:21 48:
13 263:19 296:22
numerous [1] 274:22
nursing [1] 23:2
NUY [1] 84:16
Oo=clock [3] 15:19 171:4,5
o=clockB-is [1] 301:22
obesity [1] 46:5
objectives [1] 7:1obligated [1] 14:22
obligation [1] 215:14
observe [1] 182:8
observed [3] 19:10 32:20 183:9
obstacle [2] 291:10,11
obtained [1] 8:5
obviate [1] 254:10
obviously [28] 69:17 78:12 82:12,
18 93:16 96:8 110:8 115:15 118:2
123:4 128:9 134:16 152:10,22
156:11 178:4 191:22 192:14,22
199:21 211:6 213:16 228:8 236:9
238:7 279:15 280:7 291:6
occasion [1] 155:21
occasional [1] 163:9occult [1] 126:8
occur [11] 10:18 22:7 27:12 42:9
43:13 65:9 112:5 160:4 170:1 187:
17 222:6
occurred [1] 102:16
occurring [2] 32:5,13
occurs [4] 72:4 160:14,20 161:3
October [2] 1:7 313:2
off-label [2] 289:9 298:16
off-treatment [2] 131:7 268:3
offer [4] 163:4 213:15 241:2 311:
12
offered [12] 83:5 124:5 125:4,13
129:9,10,15 130:21 138:19 140:7217:13 279:4
Office [1] 8:6
Officer [4] 3:25 5:10 6:5 180:7
offices [2] 87:5 126:6
often [16] 25:5,20,22 32:7 38:12,22
41:13 86:17 114:11 150:21 153:
14,15 161:2 221:5 282:13,15
okay [9] 131:18,19 203:6 226:8
244:18 257:21 269:2,22 284:13
old [7] 82:16 190:8 299:9,10,11
300:2,2
older [1] 21:20
olds [2] 298:1,2
oligonucleotides [1] 12:11
OLT [1] 80:9
on-Band [1] 176:14
onB-is [1] 176:16
once [14] 27:5 48:1,6 53:4 54:19
55:1 83:3 91:9 121:8 169:16 187:
11 206:21 212:9 230:10
one [146] 8:18 11:6 13:11 15:19 17:
22 18:10 20:11 27:15 29:19,20 32:
17 37:21,22 39:9 40:14 43:20 45:9,14 53:15 56:6 61:19 64:11 65:
20 66:12 69:17,22 70:12 73:5,7,8
74:11 76:11 77:4,5,21 78:15 79:1,
5 80:11 88:19 89:22 94:19 95:3
96:8 101:20 103:4 107:6 113:7
115:20 117:14 118:17 119:19 122:
8,15 123:9 124:4 125:4 127:17
129:13,14,19 130:5,21 135:8 144:
7,13,19 147:20 155:10,11 158:4,
12,17 159:18 160:2,3,16 171:5
174:20 175:20 176:22 177:2 178:
11 179:18 182:14,15 186:22 188:
17 189:2 192:11 194:19 198:9
200:18 202:13,17 205:12,14 206:
15,20 212:20 213:1 218:7,16 221:20 222:16 224:6 226:17 229:9
231:6 234:1,21 239:21 240:20
252:20,21 253:1 256:4 262:1 263:
7 264:14 265:4 267:4,7 270:15
272:1 275:20 279:4,14 280:1 281:
10 282:2 290:8,11 291:4,21 298:9
299:7 302:2 303:13,14,18 305:11
306:17 308:6,17,22
one-by-one [1] 229:22
one-stop [1] 206:19
one-way [1] 158:20
ones [4] 43:15 239:4 273:9 295:13
ongoing [17] 57:18 90:4 110:9
147:12 149:7 162:3 177:18 180:10 183:2 215:21 216:3,13,18 217:
21 224:20 233:8 264:14
ongoing-Blet=s [1] 136:11
only [34] 43:20 46:14 56:14 65:20
66:6 68:10 114:3 117:5 122:10
139:12 140:5 145:21 149:10 153:
4 157:18 159:14 161:19 165:16
187:3 206:22 219:19 225:5,6,7
249:10 254:13 255:9 257:13 265:
11 272:18 279:7 293:15 294:21
306:9
OPEN [9] 1:5 3:27 15:19 171:6,15,
17 172:14,19 308:17
Opening [2] 3:2 4:2
opinion [11] 107:7 121:7 175:21176:15 198:8 205:13 208:7,15,21
280:16 303:18
opinions [4] 107:9 115:13 122:4
211:21
opportunities [1] 51:21
opportunity [10] 80:14 108:15
138:16 142:11,17 171:7,17,20
180:1 276:5
opposed [6] 111:19 154:13 184:
22 238:9 302:15 303:6
opt [2] 137:3 249:20
Sheet 17 need - opt
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 18/28
opted [1] 141:20
optimal [2] 68:2 290:4optimist [1] 83:11
optimistic [2] 133:15 136:5
optimistically [1] 280:1
option [4] 129:20 140:5 179:12
217:17
options [5] 102:19 113:2 129:18
140:14 268:4
oral [12] 94:19 97:7 100:15 101:3,6
104:4 130:16,17 172:20 176:17291:6 292:14
Order [11] 3:2 4:2,4 68:8 142:19
161:10 192:9 200:7 229:18 296:
13 309:21
organ [6] 204:10 217:13 225:8 276:
9 279:4 280:8
organization [2] 84:15 86:5
organizations [2] 87:6 88:18
organs [2] 23:18 276:10
orient [2] 51:7 74:19
original [5] 152:2 215:18 224:21229:3 232:13
orphan [1] 215:4
other [115] 8:21 9:3 11:16 17:11
18:14 19:22 20:5 24:4,17 29:2130:4 34:16 35:5,16 46:13 52:2,12
55:15 59:8 60:10 78:5 80:21 86:
10,15 94:4 98:14 99:18 103:4 104:
13 107:5,8 113:16 114:1 115:2
117:2 118:10,15 122:4 128:9 130:
7 131:12 132:1 135:20 149:1 151:
15 157:14 158:15 160:10 163:10
164:15 165:3,7,13 173:4 182:20
184:5 193:13 196:5 204:11 207:9
210:3,10 213:12 214:4,6,7 215:17
219:21 220:9,19 222:10 232:5
233:3 237:15 238:19 239:4,6 243:
22 244:1,22 245:17 247:19 249:7
252:16 257:16 259:4 260:17,22266:13,15,18 268:1,6 272:2 277:2,
12 278:19 279:15 282:2 283:2,18
284:20 286:11 287:2,10 288:2
290:8,9 291:4 292:3 295:21 302:
14 305:4 307:21 312:1
other=s [1] 56:15
others [15] 12:11 78:13 92:4 136:7
146:3 151:6 195:19 206:8 213:5
221:15 239:16 274:10 286:10 293:
1 310:1
otherwise [4] 95:17 103:14 141:6
255:12
ought [3] 159:11 262:20 307:22
ourselves [2] 221:15 294:15
out [63] 23:17 27:4,8 30:7 32:6 33:9 58:9 66:18 77:7 84:12 94:3 96:
14 97:3 102:16,19 105:17 136:1,3
137:8 144:20 147:5 158:11 162:7
164:22 172:9 183:8,21 191:16
196:6 199:19 200:8,15 204:22
217:2 220:15 222:7 227:4 230:10
239:4 243:11 257:21 263:8 268:
13 269:13 270:7,17 272:10,14,20
281:14 283:10,15 284:2 285:8
289:8 293:8 296:15 299:4,20 300:
20 308:15 310:5,6
outcome [12] 39:4 42:11 53:16 54:
1,9,21 116:14 149:13 168:6 224:9
253:2 279:19
outcomes [3] 43:2 44:17 233:6
outliers [1] 42:15
outline [1] 107:17
outlined [1] 68:22
outside [7] 8:2 67:22 172:3 180:9
198:12 294:22 295:2
outstanding [2] 190:21,22
over[33]
10:3 19:14 27:11,12 29:13 36:12 37:11 46:1 48:22 50:19
74:5 86:13 87:1,2,11 100:15 107:
20 110:12 112:7 117:10 129:19
133:13 150:16 170:15 175:22 248:
21 254:18 263:7 286:2,10,15,15
289:3
over-call [1] 160:12over-representation [1] 21:20
overall [7] 25:14 71:5 148:14 230:15 249:16 271:21 310:10
overcome [1] 200:19
overlap [1] 210:2
overlaps [1] 273:7
overly [1] 240:10
overnight [1] 86:17overview [2] 16:19 285:13
overwhelmed [1] 92:15
overwhelming [1] 298:19
owing [1] 73:2
own [6] 198:17 201:22 242:4 248:7
271:8 285:16
Pp.m [3] 1:8 171:13 313:1
P450 [3] 259:6 261:20 268:16
Pacific [1] 286:7
package [2] 271:15 294:9
page [4] 8:1,2 17:3 142:22
paid [3] 92:19 234:15 289:10
paired [2] 239:3,5
panels [1] 95:7
paper [2] 26:19 41:2
paradigm [6] 14:16 39:10 95:4
162:17 240:16 280:12
paradigms [2] 37:13 82:16
parallel [4] 37:1 261:22 262:12
263:3
parameter [4] 31:2,6 37:22 43:9
parameters [4] 40:1 41:5 43:7
266:13
paraphrased [2] 49:20 222:15
paraphrasing [1] 302:18
parenchyma [1] 67:22
parenteral [2] 118:8,20parenthetically [1] 49:20
Parklawn [1] 8:7
parroting [1] 302:7
part [32] 6:16 30:7 38:15 52:20 96:
12 107:10 108:3 112:5 113:1 138:
12 145:18 152:12 163:18 191:13
192:15 193:8 223:11 224:4 229:
18 232:2 235:9 237:5 244:3,17
256:21 262:15 269:5 281:3 287:8
289:18 292:21 294:19
partial [5] 116:20 192:5 193:4 235:
18 236:21
partially [2] 30:21 68:11
PARTICIPANTS [7] 2:1 8:22 9:1,
3,21 194:12 241:18
participate [1] 137:18
participating [2] 7:21 8:14
participation [1] 137:20
particular [22] 7:7 8:18 19:22 22:
11 30:16 31:9 33:22 72:16 74:22
79:7,8 93:3 121:15 159:5 168:6
205:12 206:6 219:8 242:16 258:
17 261:16 312:14particularly [22] 19:13 25:4 27:9
35:19 45:2 60:6 67:15 79:19 91:4
146:20 158:13 178:3 188:21 190:
4 220:20 238:13 246:8 248:2 267:
20 268:12 275:18 285:13
partly [2] 208:20 274:4
partners [2] 24:10,11
parts [4] 17:10,11 245:17 247:19
passes [2] 89:6,11
past [5] 87:1,8 114:9 148:7 186:19
pathogenesis [3] 51:10 52:7 303:
10
Patient [62] 2:17 12:19 13:5 14:3,
12 15:7 19:11 20:11 25:18 33:22
34:13 35:1,6,6,8,13,21 41:13 42:13,21 44:21 51:19 64:21 70:21 74:
4 78:14 87:3,12 90:9,15 115:3
116:1 121:8 126:22 127:13 134:2,
4 137:7 144:21 153:8 166:10 181:
21 182:17 192:13 193:10 194:6,
13 196:21 197:11 204:18 206:15
208:5 209:10 210:7 219:19 241:6,
15 242:17 259:13 278:22 281:7
283:6
patient=s [1] 27:8
patients [218] 10:19 13:1 23:2,19,
20 24:9 26:2,22 27:7,12 34:9 35:4
36:21 37:2,11 38:1,22 40:9 43:15
45:12,17,22 46:1,4 47:8,9 48:1451:3 52:15 53:7,15 58:11 61:13
64:8,9 65:19 66:19 71:15 76:7,14
77:10,12 78:2 79:13 80:3,20 82:
19 86:22 93:3 102:11 110:15,18
111:3 112:2 115:6,9 116:18 117:4,
8 118:7 119:7,18 121:11 123:13
126:5 127:1,20 128:1,5 130:4 134:
4,17 135:21 136:1,15 137:2,5,22
138:11 141:16,19,21 142:2 143:1,
9,12 145:7,11 150:8,17,22 151:11
152:3 153:13,18 154:22 160:1
164:20 165:1,1,3,18 167:5 168:5,
19 174:15,17 175:22 176:2,3 177:
9 178:2,3,5,6,13,19 179:1,3,7,12,
21 181:16 182:1,3,6,8 183:1 184:4 187:9 190:12 191:17,18 192:3,
14 193:6,14,15,16 194:3,7,9,12,17
195:3,10,22 196:8,15 201:22 203:
5,9,10 204:2 207:5,10,13 213:13
214:17 216:2 217:22 218:12 222:
4 224:3 232:12,14 233:1,12 234:5
236:11 238:5 241:17 244:2,7,8
247:16 249:18,20 252:17 259:8,
18 267:20,22 268:4,10,18,20 269:
8 270:10 272:3,5,16 273:8 274:2,
3 275:6,8,14 276:7 277:11 278:19,
19 280:4,7 281:13 282:14 283:8
284:8 285:19 290:5 292:2 293:5
298:11 301:11 311:2,3,8,9
patients= [1] 128:6
pattern [1] 236:15
patterns [2] 64:20 133:11
pause [1] 132:22
pay [1] 288:19
paying [1] 102:17
payment [1] 173:3
PCR[1]
70:11peak [1] 21:16
peaks [1] 48:16
pediatric [12] 4:20 5:1 112:2 115:
1 164:10 180:14 285:14,19 286:
21 287:11 290:4 298:15
pediatricians [2] 289:20 290:4
pediatrics [16] 13:16 112:1 114:
20 154:20 164:3 258:13 285:11
287:22 289:15,19,21 290:11,17
292:22 295:15 300:5
pedigree [1] 240:17
pedigreed [2] 236:12,17
pedigreeing [1] 178:19
peer [1] 50:18
peers [1] 189:5PEG [11] 36:9 84:18 91:20,22 100:
11,18 103:3 104:5,21 151:7 288:1
PEG-interferon [4] 41:3 42:5 287:
21 291:13
PEG-interferon-ribavirin [2] 94:
15 234:5
PEG-ribavirin [2] 84:19 308:4
pegylated [17] 11:12 13:22 14:18
34:14 71:2 73:15 115:22 116:10
118:1,9 130:2 131:10 148:5,10
149:1,3 254:20
pegylated-interferon [7] 287:13,
15 288:5,9 290:14 294:17,19
pegylated-interferon-ribavirin[1] 134:11
penchant [1] 125:21
pending [1] 177:12
penicillin [2] 83:4 251:4
people [128] 4:14 17:18 20:2 22:8,
12 23:1 38:19 47:13 55:16 56:22
86:7,8,14 88:2,11 91:10,19 92:1,4
93:3,4 94:10 95:6,12 98:4 99:3,5
100:10 101:5 102:11,14,18 103:
19 104:8,10,14,17,21 112:14 142:
15 147:4,11,21 148:3,6,10,15,18,
19,20,21 150:9 152:10 171:6,19
172:8,9 186:22 187:11 199:4,15
200:13 201:2,6,17 203:1 205:17
206:1 212:12 214:1 215:7 216:21219:21 220:1,5,16,18 222:10,18
223:7,11 226:5 230:8,22 231:17,
19,21,21 239:20 240:7,12 241:2
242:5 244:12 245:3 258:1 260:17,
21 261:15 264:20 265:19,19,21
266:8 269:14 271:13 273:1 275:
22 276:3 283:9 285:10 288:19
289:1 292:10 296:12 297:19 302:
11 306:3,15,18 309:19,20 310:2,
15 312:10,15,17,20
peopleB-I [1] 223:6
Sheet 18 opted - peopleB-I
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 19/28
peptides [3] 55:10 56:1 182:12
per [9] 10:21 19:6 22:4,14 48:4,5
54:15,17 160:6
percent [79] 30:20 31:8,8,9,9,20
33:7,8,20,21 34:1,3 35:8 43:19 44:
22 45:2 46:14 48:4,5 53:15 54:14,
17 55:3 58:16 64:15 65:9,10,21
66:8,10 71:7,8,9 72:7 74:5 75:21
88:2 109:14 113:15 116:9 117:10,
21,22 121:18 123:20 127:3,21
128:5 136:2 144:15 148:14,15149:5 165:1 174:16 175:17 176:1
181:22 191:21 199:1,6,11 217:11
228:16,16 231:11,18 238:10 240:
14 247:11,14 248:21,22 274:17
286:2 306:17 310:9,10 311:11
percentage [9] 22:9 45:5 91:18
194:17 195:21 286:3,22 307:9,12
percentages [2] 69:14 287:2
perfect [4] 240:17 261:13 305:17
310:13
perfectly [1] 281:14
performed [1] 156:4
perhaps [60] 32:16 52:22 63:6 64:
13 69:8 72:14 85:20 97:6,19 98:2,
15 101:20 111:18 112:17 114:13117:10 122:3 123:6,12 124:14
125:10 131:14 140:1 141:15 143:
9 146:20 147:18 152:17 155:1
156:9 157:18 161:13 163:13,15
169:20 181:9 184:16,17 210:1,5,7,
14 211:9 220:18 222:5 225:21
235:13,17 236:3 240:3 241:8,21
242:12 250:21 253:1 274:2 281:
13 285:12 298:12 307:17
period [25] 22:5 27:12 38:13 39:14
40:11 45:7,18 63:14,21 67:5 68:
12 114:18 115:10 128:3 131:6
133:13 134:10,12 136:13 147:2
157:19 158:21 230:22 238:20 252:17
periodic [1] 141:22
periods [7] 26:10 119:13,17 130:
12 157:17,21 169:4
peripheral [2] 183:16,19Perleson [1] 42:6
permit [1] 164:13
permits [1] 38:7
perplexing [1] 76:19
persistence [1] 57:16
persistently [2] 53:21 70:14
person [6] 48:1 84:19 115:20 147:
2 198:3,5
person=s [1] 53:11
personal [5] 75:14 82:17 104:18198:17 201:22
Personally [3] 77:10 201:7 291:20
personnel [1] 24:1persons [1] 269:10
Perspective [17] 3:8,20,24 9:11,
14 10:13 15:17 82:17 83:19,20 84:
5 106:8,15 107:11 138:8,9 300:8
persuade [1] 167:17
pertinent [2] 62:3,16
perturbation [2] 30:1 31:17
perturbed [1] 56:19
pestiviruses [1] 18:10
Peter [3] 2:8 5:1 242:9
Peter=s [1] 158:3
Ph.D [6] 2:2,9,14 3:3,13,29
Pharm [1] 3:6
pharmaceutical [2] 44:10 210:16
pharmacodynamics [1] 222:13
pharmacogenetics [1] 98:12
pharmacokinetic [4] 260:3 264:7
266:17 285:1
pharmacokinetics[6]
224:17227:14,20 268:12 301:7,14
pharmacologic [1] 50:22
pharmacologically [1] 42:2
Phase [34] 12:20 31:18 32:3,8,15,
17,19 33:15 35:7,10 36:12 37:1
48:11 72:3 94:20 97:6 101:8 114:
14,21 159:21 183:22 184:12 211:
15 212:9 215:22 230:11 232:19,
19,20 257:6 270:13 282:8 305:18,
20
phases [2] 154:12 241:20
phenomena [1] 204:22
phenomenon [1] 65:15
Philip [3] 3:30 186:12,16
phosphorylated [1] 62:8phrase [3] 229:10 232:8 296:18
PhRMA [1] 262:15
phylogenetic [2] 19:19,20
physical [1] 293:15physicians [4] 201:4 207:7 272:
22 310:1
physiologic [1] 47:19
pick [1] 233:17
picture [3] 17:6 28:7 47:16
piece [2] 216:13 293:7
pieces [1] 135:19
piercing [1] 24:19
pike [1] 285:21
pill[1]
291:8pills [1] 291:8
pilot [16] 212:17 216:2 217:20 222:
2 226:22 227:1,10 229:10,13,17
230:3,12 254:6 262:20 263:6 268:
19
pipeline [1] 12:1
pivotal [6] 40:14 41:3 131:21 270:11 309:3 310:12
PK [22] 206:6 222:5,12 225:22 226:
12 227:12 261:20 262:20,22 263:
18 288:16 296:21 297:5 298:4
299:8,10,12 300:9 301:19 305:12,
19 311:22
PK/PD [2] 227:5 285:18
place [8] 33:8 41:15 101:17 177:17,17 276:11 282:6,10
placebo [15] 13:21 77:9,11 78:4
79:15,16 118:12,20 119:3,10,20
130:17 139:6 143:6 150:3
placebo-like [1] 134:10
placed [2] 106:22 277:12
places [2] 20:17 43:21
placing [1] 195:3
plan [3] 235:4 243:2 307:22
planned [1] 232:6
planning [3] 83:14 226:5 307:18
plans [1] 177:15
plaques [1] 10:1
plausible [1] 262:1
play [1] 218:6
playing [2] 69:7 207:2
plea [2] 195:18 311:7
pleasant [1] 231:8
please [7] 4:11 173:16,19 186:13
197:15 216:1 305:9
pleased [1] 198:22
pleasure[1]
50:17plot [1] 31:13
Plough [5] 3:28 174:2,4 179:14
291:16
plunge [1] 107:22
plus [8] 14:18 77:8 94:15,16 103:3
149:4 242:2 287:14
plus/minus [2] 94:14 256:12
point [77] 20:7 26:13 28:6 33:14
37:22 44:8,8,16 45:18 46:18 52:3
63:16 64:2,15 66:8 77:7 85:16 88:
14 97:13,15 98:5 101:2,16 103:10
144:18 146:4 149:18 152:11 155:
6 156:8 157:14 159:6 168:1 171:1
176:20,21 177:15 189:2 191:16
192:15 197:1,2 202:22 203:3 206:14 210:9 211:14 212:17 214:22
223:13 226:20 231:9 232:4 237:
20 239:19 240:2 242:9 244:16
246:21 250:3 253:14,20 254:22
267:4 271:2 288:15 289:6,13 290:
9 292:20,20 298:4 299:2 300:1,20
310:6 311:13
pointed [8] 58:9 66:18 147:5 183:
8,21 191:16 196:6 204:22
pointing [1] 270:17
points [16] 11:3 20:6 43:3 81:10
90:18,19,21 108:6 124:13 165:8
181:1 187:4 203:7 229:22 290:9
310:8politician [1] 146:16
poly-drug [1] 99:4
polyclonal [1] 55:13polymerase [7] 12:8 19:8 94:16
95:17 102:8 145:17 153:7
polymerases [1] 176:10
pool [6] 27:15 28:5 31:22 44:5 79:2 178:13
pooled [2] 34:10 192:19
poor [4] 202:9,9 266:21 275:13
poorly [4] 27:17 76:2 174:22 191:
18
populated [1] 305:21
population [128] 10:16 14:3,12 15:
8 19:15 21:18,18 36:5,9 42:13 54:15 55:5 63:2 65:17 69:19 72:16,
22 73:1,5,10,11 74:21,22 78:11
80:10 88:9 90:10 91:14 94:1 98:7
99:20 108:21 109:15 113:8,12,21
114:2,9 115:3,4 116:15 124:22
138:10,14 145:12,22 146:9 151:9
153:9,17 162:4 163:8 187:7 188:
19 189:1,3 190:13 193:19 194:21
197:11,19 199:14 206:9 209:4,5,
15,20,21,22 210:13 211:6,8 213:8
214:22 216:15 217:4,8 224:19
225:20 227:13 229:14 230:7,13,
14 232:15 233:9,22 234:2,16 235:
4,14,15 236:8,8 237:4,5 238:7
239:15 240:17 243:6,10 248:19
259:13 261:10 262:9,20 264:4
265:3,5 267:5,10 270:18 273:2,13
279:5,9 281:7 286:21 287:5 288:
22 297:18 299:13 300:3,6 304:16
308:20 309:6 311:19
population-specific [1] 305:19
populations[92]
7:4 12:19 13:619:13,14 21:1 22:21 27:10 36:17
45:2 50:10 51:19 64:21 66:14 75:
12,15,17 76:13,15,18 78:10 87:3,
21 88:13 90:11,15 91:4,9 92:2 93:
1,2,7 98:9,13,21 99:6 111:7 117:5,
16 119:12 121:2 134:2,5 135:11
141:5,15 177:4,13,13,16 188:21
189:10 196:21 206:1 208:6 210:1,
20 211:2 212:2,8,18,20,22 213:3
226:1 229:11 230:4 233:15 234:7
237:1,4,16 238:22 242:20 243:21
251:1 262:10 263:21 270:20 285:
14 297:4 298:15 308:8 309:9,10,
16,22 310:3,13 312:2,12,15
populationsB-the [1] 69:14pormise [1] 92:6
portal [7] 47:16 67:13,19 68:1 167:8 195:13 205:1
portends [1] 287:4
portions [1] 25:15
posed [8] 14:8 106:20 107:15 110:
1 111:12 115:12 171:9 216:11
position [2] 243:19 290:3
positive [9] 18:8 23:21 24:11 26:8
117:11 136:14 178:16 229:18 266:
5
positively [1] 293:14
possibilities [1] 169:16
possibility[7]
129:16 144:16 169:22 222:17 239:22 240:4 296:8
possible [25] 80:14 82:1 103:21
107:7 112:13 120:13 123:3 131:
20 136:20 139:5,6,21 189:1 197:4
199:18,20 200:7,9 201:13 207:3
221:14 225:10 281:2 298:7 311:
17
possibly [10] 14:13 52:11 127:22
128:14 129:10 132:17 158:21 159:
1 239:11 296:7
post [43] 13:13 39:16 64:16 68:17
71:14 76:16 77:21 80:9 88:12 93:
5 100:7 127:6 128:3 138:7 144:21
221:17 226:10,10,11 228:9 258:
10 273:6,10 274:7,13,14,16 275:9276:8,12,17,19 277:18 278:9 279:
13,18 280:14,21 281:9 282:8 284:
6,10,18
post-approval [1] 114:18post-market [1] 124:6
post-marketing [5] 114:14 154:
13 212:14 230:22 285:4
poster [2] 104:16,19
postoperative [1] 112:1
potency [2] 165:21 166:1
potent [1] 219:1
Sheet 19 peptides - potent
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 20/28
potential [23] 7:14 8:9,11 44:6,1467:8 69:4 79:13,15 81:11 102:9
162:9 191:9 196:7 204:7,19 219:2
241:11 277:16 279:12 280:11 282:
2 293:11
potentially [17] 81:14 132:14 133:
2,19 162:22 184:5 200:14 209:2,5,
11 210:11 213:18 222:12 246:16
282:12 303:12 308:10
potentials [1] 203:20
power[3]
213:7,9 238:11powered [2] 167:15 302:8
practical [2] 7:14 66:6
practice [1] 311:9
practices [1] 281:17
practitioners [1] 288:19
pre [14] 13:13 68:16 88:12 93:5
111:22 220:19 221:17 258:10 273:
6 275:10 284:5,11,18 293:1
pre-approval [1] 271:15pre-INDs [1] 12:7
pre-intent [1] 279:8
preambles [1] 295:21
precede [1] 277:4
precipice [1] 89:15
preclude [2] 6:16 173:11precondition [1] 281:22
predicated [1] 70:20
predict [8] 29:3 40:9 92:3 124:11
164:6 168:9 181:1 279:1
predictability [1] 268:17
predicted [5] 34:6,20 71:18 82:9
163:16
prediction [4] 34:19 38:9,16 39:
20
predictions [4] 39:8 48:10 49:10
169:19
predictionsB-future [1] 48:21
predictive [6] 28:21 33:4 35:2 40:
16 41:7 123:18predictor [1] 164:1
predictors [4] 38:18 39:5 40:6
177:5
predicts [1] 36:1
predominance [1] 20:17
preexisting [1] 242:14
preface [1] 107:18
prefer [9] 139:18 155:8,12 156:3,4,
6 187:16 189:16 289:16
preferably [1] 187:18
preference [1] 228:2
preferred [4] 121:1 130:3 140:15
155:21
preformed [1] 61:19
preliminarily [1] 72:11preliminary [1] 274:11
premature [1] 124:14
prepared [4] 7:17 9:7 156:9 190:
20
preparing [1] 126:21
prerequisite [1] 197:18
prescribed [1] 116:9
present [7] 9:10 15:16 71:13 126:
9 144:9 160:7 284:7
presentation [9] 56:1 107:17 112:
6 161:5 172:17 180:19,22 183:8
194:1
presentations [1] 271:21
presented [5] 22:16 72:11 94:12
99:14 256:10
presenters [1] 88:2
presenting [4] 11:6 15:12 83:19
184:10
president [1] 174:2
presumably [10] 30:1 49:15 65:13
119:9 152:16 155:9 202:4 247:18
273:20 279:18presume [2] 198:12 306:11
presumptively [1] 282:12
pretreatment [2] 38:18 39:5
pretty [10] 35:2 84:6 85:5 88:18
100:5 105:22 218:18 238:18 273:
1 311:15
prevalence [7] 21:16 24:7,16 77:1
309:5 311:18 312:15
prevalent [2] 20:20 99:6
prevent [6] 81:20 130:9 140:17
279:11,20 282:9
preventable [1] 50:21
preventing [2] 154:1 282:6
prevention [3] 82:10 167:11 282:
22previous [3] 9:5 116:8 236:12
previously [8] 108:2 115:5,20 148:
1,16 237:9 287:17,18
pricing [1] 234:11
primarily [6] 18:22 21:2 194:14
244:14 309:9 311:4
primary [21] 7:1 25:5 77:19 78:7
79:17 82:6 120:4,11 122:19,20
124:5 126:16 127:17 139:11 175:
8,11 232:13 233:4 257:20 263:20
272:21
principal [1] 74:13
principally [3] 65:19 67:6 73:9
principles[1]
219:16prior [18] 23:15 43:14 51:17 59:17
133:11 142:6,9 197:18 268:8 271:
20 272:12 274:7 278:6,15 297:2,4
298:6 301:17
priorities [1] 221:9
prioritize [2] 128:18 276:17
priority [8] 75:15,22 76:17 129:2
194:4 195:6 247:16 253:11
prisoners [1] 23:1
pristine [1] 218:13
probability [2] 70:15 79:21
probable [1] 202:2
probably [42] 20:8,21 30:12 39:2
59:4 77:19 84:17 86:14 87:9,10
93:22 95:8 127:11 136:18 137:11138:6 143:21 152:5 169:3 176:1
179:16 205:13 206:11 210:16 213:
3 227:2 232:18 238:18 244:3 260:
8 263:1,5,17 267:7 268:19 269:15
277:1 278:3 286:19 298:1 307:9,
10
problem [13] 30:19 53:6 67:10 68:
4 96:12 129:6 179:9 221:3 223:2
245:11 274:21 293:17 306:4
problematic [6] 67:15 79:12 80:
12 121:5 241:16 275:12
proceed [3] 91:1 122:2 293:12
proceedings [2] 171:11 313:1
process [24] 22:1 23:17 25:4 28:7
29:19 38:3 44:1 45:8 46:16 54:20
172:12 204:5 215:3 228:12,12
232:3,6 244:4 260:13,19 263:6
281:4 296:6 298:6
processB-is [1] 220:10
processes [2] 96:21 249:7
prodrug [1] 81:5
produce[3]
28:4,6 266:5produced [3] 11:15 56:10,10
product [7] 7:7 13:16 71:2 187:22
248:14 294:10 296:1
production [18] 28:13,14 29:14
30:4,7,9,20,21 31:4,7 32:3 56:16
59:7 60:14 61:18 62:21 63:5 183:
15
productive [5] 27:19 67:18 75:22
77:12 189:18
productively [2] 27:21 28:4
Products [18] 3:10,15,25 6:6,10,
21 8:21 9:6 10:12 11:10 12:2,5 21:
4 50:13 134:22 138:17 177:3 306:
2
Professor [1] 3:17profile [9] 70:1 82:1 83:2 132:18
133:18 194:16 285:22 290:16 308:
7
profiles [2] 179:19,20
program [1] 210:19
programs [2] 86:12 180:10
progress [9] 45:10,22 46:2 54:4
66:20 78:22 88:4 174:13 298:19
progressed [1] 268:5
progresses [1] 46:18
progressing [2] 108:15 220:2
progression [16] 28:22 45:20 46:
6,17 53:5 54:5 74:3 75:1 82:10
126:17 128:7 149:15 259:2 280:5281:12 285:13
progressive [5] 187:8 274:15 284:
8 286:9 306:20
progressors [1] 281:9
proinflammatory [1] 63:4
Project [3] 3:22 83:18 89:1
projected [1] 196:1
prolonged [2] 140:17 153:16
promise [5] 124:6 226:6,11 227:
11,12
promised [1] 263:9
promising [2] 114:21 177:11
promote [2] 57:16 61:14
prone [1] 103:14
prophylactic [1] 182:19prophylaxis [2] 282:22 284:10
proportion [2] 306:15 311:18
proportions [1] 308:12
proposal [1] 263:7proposals [1] 192:11
proposed [1] 276:14
proposing [1] 248:13
prospect [1] 279:8
prospective [1] 254:16
prospectively [2] 215:5 254:14
protease [22] 12:8 85:4,8,13 86:4,
9 91:15,16,20 95:16 102:7,15,16
103:4,13,15 145:17 151:17 153:6
260:5 266:17,19
proteases [1] 176:9
protect [1] 204:18
protected [1] 144:11
protein [1] 61:18
protein-mediated [1] 57:9
proteins [6] 18:19,20,21 55:11 59:
14 61:2
prothrombins[1]
110:22protocol [3] 210:18 215:1 281:10protocols [3] 106:18 122:3 280:20
proud [1] 295:9
prove [6] 96:18 100:21 101:8 124:
7 132:16 134:13
proved [2] 83:4 242:1
proven [4] 61:11 95:17 103:14
283:12
proves [1] 297:18
provide [11] 12:3 16:19 41:8 85:4,
11 86:20 117:15 205:16 214:20
249:1 268:16
provided [3] 28:17 173:14 274:10
providing [3] 86:16,22 142:2
psychiatric [2] 312:11,17pt [1] 126:4
Public [16] 3:27 5:20 15:19 24:8
85:9,10 171:6,15,17 172:12,14,19
173:15 196:17 228:20 298:22
publication [1] 128:3
publications [1] 86:18
publicly [2] 194:18 234:13
published [10] 25:18 26:19 71:21
97:16 129:5 146:3 147:14 148:13
153:20 164:21
Pugh [3] 128:16 129:1,8
purely [1] 70:2
purine [1] 62:11
purpose[3]
137:12 156:7 173:12purposes [4] 65:15 77:5 110:6
213:7
pursue [1] 248:11
pursued [1] 257:7
purview [2] 57:6 234:11
push [1] 300:9
pushed [1] 265:4
put [6] 10:13 92:13 124:8 210:18
235:20 271:5
putative [1] 62:2
putting [5] 35:20 85:13 230:1 240:
21 270:7
Q
qualitative [1] 25:10quality [4] 43:3 82:13 252:3 293:
17
quantifiable [1] 251:21
quantification [1] 286:18
quantitative [1] 25:12
quarter [1] 306:17
quasispecies [3] 19:13 20:9 242:
15
question [72] 14:8 18:13 83:7 111:
6,19 142:11 144:8 145:4 147:7
150:6 154:5,8 155:4 156:1,15 157:
6 158:16 161:8 163:11,18 164:5
Sheet 20 potential - question
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 21/28
166:2,13 167:19 168:14 169:8,13
178:11 179:11 195:15 197:9 198:
1 200:6 208:10 211:14,17 212:1
216:11 220:3,13 221:9 225:13
226:3 233:10 240:12 243:8,14
244:6,19 246:3 247:12 248:8,10
249:9 258:14,19 264:12 265:7
266:20 267:14 269:4 272:11 277:
14 280:15 282:15 284:15,15 292:
16 293:20 305:22 306:1,21
questioned[2]
14:20 15:3questions [29] 12:16,17 15:20 36:
19 95:1 97:1,2 106:20 107:2,14
109:22 111:12 114:12 115:13 137:
21 138:20 142:8,20 144:19 149:
11 154:16 159:4,5 169:7 171:9
195:7 196:19 197:2 200:18
Questions/Clarifications [2] 3:
26 142:5
Questions/Discussion [2] 3:32
196:16
quickest [1] 205:16
quickly [15] 27:21 35:12 46:2 105:
15 108:4 133:3 160:21 195:17
199:18,20 200:7 220:1,14 222:8
281:2quite [17] 48:19 64:7 72:2 77:1 85:
15,18 111:10 160:14 174:12 182:
10 183:6 190:10 282:13 286:5
290:5 291:6 296:5
quits [1] 179:11
quote [1] 49:19
RRAC [1] 84:16
race [2] 71:19 199:11
racial [10] 13:18 76:12 112:19 258:
14 301:22 302:3 303:13,19,22
311:17
radio [1] 89:20
radiology [1] 67:16
raise [5] 101:10 103:16,18 211:7
235:2
raised [7] 149:11 178:7 193:22
223:7 259:5 309:1 310:16
raises [4] 150:1 169:15 201:11
277:14
raising [2] 36:19 210:9
ran [1] 102:19
randomize [1] 297:9
randomized [6] 80:16 218:13 239:
13,14 297:12 298:5
range [4] 27:3 34:3 111:1 301:11
ranges [2] 26:12 141:11
ranging [1] 199:1rapid [12] 31:17 40:5 42:19 63:17
70:8 159:22 183:17,19 209:6 264:
8 271:12 281:12
rapidity [1] 63:15
rapidly [6] 46:19 112:15 187:8 277:
22 278:10 284:8
rare [2] 22:7 65:15
rarely [1] 290:18
rate [33] 27:22 30:12,15 43:10,17
45:1 48:2 54:2,14,16 69:10 72:21
111:18 127:21 128:6 148:13,15
149:4 151:7 184:3 199:6,10 231:
16 237:10 238:9,10 247:10 255:5,
6 256:5 266:3 274:18 310:10
rates [19] 11:15 22:17 43:21 45:4
71:5 73:19,20 143:4 174:21 187:
13 198:22 240:13 249:16 256:1
271:22 275:8 291:12 294:1 302:
20
rather [13] 70:3 114:4 121:21 211:
22 212:5 225:19 237:12 240:20
242:1 257:19 273:11 299:4 308:
15ratio [1] 188:20
rationale [2] 81:13 260:20
ravage [1] 112:11
Ray [8] 16:7,8 89:19 151:2 220:18
233:18 251:12 281:5
Raymond [2] 2:16 7:18
re-emergence [1] 162:10
re-prove [1] 122:13
re-transplantation [1] 276:3
reach [5] 33:14 279:3 309:15,22
310:3
reaches [1] 86:13
reaching [1] 195:12
read [5] 6:12 89:8 171:18 172:9
245:4readily [4] 53:17 54:7 184:4 251:
21
ready [2] 206:16 241:21
real [12] 20:15 42:20 43:2 188:4226:10 237:7 250:4 282:4 289:11,
11 292:9 295:17
real-live [1] 312:19
real-world [1] 189:4
realistic [3] 189:2 260:11 263:1
reality [4] 269:13 289:12,14,19
realize [5] 101:18 188:6 189:4 242:
18 308:6
really [73] 17:2 21:22 32:12 35:19
37:20 39:19 52:3 63:19 65:4 79:8,10 82:15 92:11,14 95:20 97:14
118:3 127:19 136:10 144:20 145:
1 151:10 154:9,21 158:2,13,16
159:16 160:11 162:12 163:13 166:
4,8 174:6 184:1 190:19 193:5 195:
2,7,19,22 196:3,8,11,12 200:10
201:17 202:3,16 214:6 218:22
219:18 225:16 234:21 239:2,13
240:11 242:3 253:13 272:13 273:
7 274:11 275:15 287:3 290:3 293:
14 294:16 296:11,19 304:13 305:
18 311:12 312:13
reason [17] 70:4 109:4 127:11 129:
2 151:19 172:18 197:21 199:2
204:7 206:22 217:10 255:14 265:10 281:1 283:8 303:2 304:17
reasonable [12] 120:14 129:12
133:1 166:10 212:10 217:14 242:
7 244:11 246:5 257:10 262:5 285:
22
reasoning [1] 119:4
reasons [9] 35:16 125:20 146:11
165:3 184:19 265:17,22 298:22
300:3
Rebitrone [1] 180:14
rebounds [2] 42:9 135:22
receive [3] 109:9 138:12 141:17
received [11] 23:14,18 85:9 116:8
118:20 148:11,22 149:3 191:20,
21 214:21
receiving [1] 77:14
Recent [4] 21:14 39:22 40:4 98:1
recently [1] 71:21
receptor [1] 12:10
receptors [1] 59:11
recess [2] 106:5 258:4
recessed[1]
171:12recipients [2] 136:16 146:1
recite [1] 7:14
recognition [3] 44:13 190:13 301:
8
recognize [10] 47:8 52:8 80:12 87:
19 181:7 188:8,19 189:6 283:4
295:16
recognized [3] 26:1 188:14,18
recognizing [1] 76:18
Recombinant [1] 25:8
recomendationB-that [1] 137:5
recommend [1] 93:8
recommendation [3] 137:4 232:9,
21
recommendations [3] 87:17 185:4,7
recommended [8] 134:12,19 139:
5 141:14,19,21 196:22 249:4
recommends [1] 24:5
reconvene [6] 106:4 171:5,12 258:
2 312:4 313:2
record [5] 6:16 9:2 100:6 104:6
198:18
recorded [1] 123:19
recording [1] 173:12
recurrence [4] 160:20 161:2 276:
1 279:17
recurrent [7] 74:3,15 80:9 274:8,
16 276:8 279:11recurring [2] 122:9 135:21
recurs [1] 279:13
red [1] 65:6
reduce [8] 51:4 127:6 169:22 183:
15 184:16 255:7,15 256:3
reduced [8] 82:11 126:19 149:14,
15 162:16 178:22 255:17,18
reducing [7] 127:5 131:14 152:18,
19 236:4 255:8 256:3
reduction [11] 58:12 59:15 116:2
127:4 129:14 153:5 167:7,12 168:
19 237:12 238:20
reductions [2] 150:21 236:3
reemerge [2] 144:4,12
reemphasized [1] 54:21Reese [6] 2:3 3:6 5:9,9 6:11,14
referenced [1] 256:10
referred [2] 150:14 218:16
referring [3] 151:13 159:16 272:
16
refers [1] 116:19
reflect [1] 188:20
reflected [1] 95:5
reflex [2] 277:11 307:2
reframe [1] 198:1
regard [8] 13:5,20 14:7 15:3,4 60:
21 67:8 162:18
regarding [12] 69:1 78:14 82:19,
21 98:10 111:6 138:21 185:16
189:11 234:6 244:5 277:15
regardless [1] 208:12
regeneration [4] 28:1,2 43:13 67:
1
regime [1] 189:15
regimen [20] 14:14 78:18 81:16
121:12 124:13 134:9 150:16 158:
14 159:15 191:13 193:8 208:13249:5,19 253:5,17 256:14 266:20
278:12 303:7
regimens [14] 63:10 77:9 115:21
151:8 159:9,18,18 162:18 163:4
194:5 195:21 207:12 275:3,4
regions [3] 204:3,8 225:7
register [3] 172:7 177:2 285:6
registered [1] 249:3
registration [21] 211:15 224:4
226:10 229:19 232:13 233:16 237:
6 239:15 243:18 244:18 258:20
262:21 265:9,11 270:17,21 278:6
281:3 283:15,22 296:8
registrational [12] 114:8 138:12
221:21 222:8 223:15 225:20 227:7,9 263:4 288:18 295:17 297:16
registrationB-initial [1] 243:17
registry [1] 146:1
regular [1] 150:19
regulated [1] 8:16
Regulatory [7] 3:23 106:8,14 107:
10 138:8 177:7,11
reinfected [1] 152:20
reinfection [3] 144:17 282:6,10
relapse [11] 65:8 75:9 121:19,19
127:3 147:4 160:3,4,14 192:14,18
relapsed [3] 190:11 192:6 237:10
relapser [1] 235:18
relapsers[7]
76:9 116:21 117:10,19 139:1 192:18 240:7
relapsers/rebounders [1] 116:
22
relate [2] 61:4,6
related [16] 7:2 10:11 12:7,17 18:9
20:4 21:3 49:1 73:8 88:15 158:18
258:13 268:12 273:12 309:8 310:
8
relates [1] 166:13
relation [1] 22:11
relationship [5] 163:20,22 164:9
172:21 264:4
relationships [5] 173:8,9 250:19
263:14,17
relative [2] 48:15 309:5relatively [10] 45:17 50:3 67:5 68:
16 127:12 187:3 202:9,9 271:22
286:8
relearn [1] 190:8
release [2] 183:16 283:5
released [1] 267:10
relevance [1] 51:16
relevant [7] 25:4 26:21 90:5 185:
15 235:1 291:6 312:19
reliance [1] 228:21
reluctance [1] 154:11
Sheet 21 question - reluctance
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 22/28
reluctant [2] 223:12,13
remain [8] 28:15 54:22 142:13 144:
11 175:19 190:4 191:13 193:8
remained [1] 104:18
remains [5] 22:10 32:12,21 144:9
151:22
Remarks [7] 3:2,7 4:2 9:11,13 108:
5 137:14
Remember [6] 27:22 74:21 145:
21 164:19 237:21 267:4
remembered[2]
123:22 139:12remind [2] 11:22 243:7
reminiscent [1] 82:21
remission [1] 161:15
remodeling [1] 167:12
removal [1] 253:1removed [2] 153:16 217:16
renal [5] 76:22 80:20 81:1 135:12311:2
repeating [1] 126:2
repetition [1] 109:2
replace [1] 247:8
replete [2] 135:17 165:18
replicase [1] 135:5
replicate [2] 19:4 52:11
replicating [1] 160:7replication [19] 18:11,14,21 52:12
56:17 58:5 59:15 62:13 63:19 68:
6 110:9 144:11 153:5 154:6 161:
13,13,20 170:2 184:22
Replicon [1] 176:11
reported [2] 19:8 194:22
reports [3] 32:18 151:5 252:4
represent [7] 8:17 107:6 117:4
198:15 232:15 304:20,22
representation [1] 13:17
Representative [9] 2:9,11,17 8:
13,15 16:12 84:16 138:10 309:11
represented [2] 81:22 114:3
represents[5]
18:18 20:12 107:13 183:19 184:1
request [3] 8:5 154:15 300:15
requesting [1] 186:11
requests [1] 214:21
require [11] 96:16 193:16 226:7
238:14 245:10 247:6 264:21 265:
8 271:14 288:16 298:6
required [12] 73:17 96:4 150:21
166:17 171:18 235:11 258:20 272:
5 284:16,22 301:13 302:21
requirement [5] 205:18 232:22
260:9 297:1 303:21
requirements [3] 245:1 288:8
296:21
requires [1] 262:14requiring [8] 82:12 193:18 206:12
226:12 245:14 246:16 272:14 302:
9
rescue [2] 78:22 204:6
RESEARCH [6] 1:3 5:18 6:19 96:
12 174:2 272:22
researched [1] 234:17
researchers [1] 105:16
resemble [1] 106:21
reserve [1] 115:1
reservoirs [1] 100:9
residual [5] 66:10 128:19,20 145:
3 161:22
resistance [41] 81:20 95:15,19 96:
1 97:8,8,11 102:2,3,9,13,15,20
103:12,14 118:18 130:11 132:9
133:11,16 135:6 158:20 159:2
176:12 179:10 190:5,6 193:7 200:
3 209:7 220:15 236:5,7 239:22
240:5,22 241:10,10 266:21 267:
11 308:2
resistant[2]
103:19 242:15resolution [3] 45:1 108:20 114:12
resolve [3] 44:22 45:3 169:2
resource [1] 86:11
respect [10] 8:12 9:3 147:19 153:3
203:21 204:20 217:11 228:10,18
280:18
respectB-it [1] 231:5
respectfully [1] 217:20
resplendent [1] 59:19
respond [23] 29:5 37:2 38:19,20,
21 39:1,7 40:10,10 92:4 98:13,13
147:4,8 157:9 178:6 183:2 199:9
203:12 220:5 249:21 278:16 304:
17
responded [6] 107:1 109:22 148:16,17 192:6 237:9
respondents [3] 107:13 109:22
132:6
responder [3] 235:18,18 239:7
responders [9] 42:19 116:20,21
175:18 193:5 236:21 238:13 239:
21 240:16
responding [3] 150:1 153:14 168:
13
response [127] 29:4 31:3 35:14 36:
1 37:16 38:2 39:9 40:6 51:12 52:
17,18 53:12,13 55:9,12,13 57:15
58:20 59:1,13 60:8,12,16 61:6 63:
7,11,17,17,18 64:3 65:4,7,8,18 68:7 69:7,10 70:9,10,13,14 71:5,12
72:4,7,8,10,15 73:4 75:8,11 76:9
98:17 101:7 111:18 112:17,22
113:5,14 114:15 116:19 117:20
120:18 123:17 125:1 139:18 143:
10,18 147:6 148:12,15 149:4 154:
16 155:8 156:1 157:13 161:11
162:3 163:17 164:7 174:21 175:3
177:6 181:13,20,21 182:4,10,15,
16 184:3 187:13 191:19 192:1,4,5
198:22 199:6,10 200:22 202:11
227:8 231:16 235:15 236:15 237:
10 238:9,10,18 240:13 247:10
248:21,22 249:16 255:5 256:5
257:9 266:2 275:8 284:5 286:16291:12 294:1 297:5 302:20 308:7
311:15
responseB-not [1] 202:9
Responses [26] 3:23 13:3 15:18
36:21 37:4 106:7,14,16 107:2,5
108:1 117:13 138:22 170:4,16
175:4,5 181:16 182:10 185:2 187:
15 188:15 203:19 243:3 307:20
308:4
responsible [1] 59:16
responsive [2] 57:3 69:15
responsiveness [4] 21:3 53:1 72:
13 262:6
rest [2] 18:20 258:6
restrict [1] 265:10
restricting [2] 240:4 268:3
restrooms [1] 4:15
result [7] 10:21 29:13 30:7 33:9 42:
13 54:11 85:9
results [6] 29:14 42:16 55:8 134:
16 291:18 312:19
resumption[1]
128:2Retanovir [1] 266:18
retard [1] 81:20
retarding [1] 154:1
retesting [1] 141:14
retreated [3] 149:22 193:16,19
retreating [1] 192:2
retreatment [9] 118:1 134:8 143:4,
8,18 147:6 158:22 192:4 237:11
retrospectively [2] 195:9 254:13
return [1] 170:20
reversal [1] 128:20reverse [1] 280:4
reversing [1] 126:18
review [2] 15:10 25:2
reviewing [1] 12:6revolutionary [1] 73:4
ribavirin [48] 11:11,13 13:22 14:20
29:21 34:14 51:11 62:3,7,19 63:3
71:2,3,7 79:11 81:4,5,6,15 84:18
91:22 100:12,12,16,22 103:4 104:
5,21 115:22 116:9 118:2,9 132:4
140:18 148:9 149:4,10 253:6 255:
8,13,16,22 256:12,21 261:4 275:
18 287:14 291:13
ribavirin-Bfour [1] 73:15
ribavirin=s [2] 81:1 132:6
ribosomal [1] 18:18Richard [6] 2:7 5:11 7:19 229:10
257:5 303:3rid [3] 231:3,10 298:21
rigor [1] 156:6
rigorous [1] 218:14
risk [43] 23:11,13 24:7,12 28:22 70:
1 75:1,3 88:3 102:12 127:13 144:
16 146:9 150:12 166:18 167:13
168:19 177:12,16 192:18 194:15
195:4 200:13 201:15 210:13,20
211:1 216:15 219:21 220:2 232:
15 235:7 236:5 240:22 241:7,9
266:21 268:2 279:19 281:11 287:
3 298:11 309:5
River [1] 20:19
RNA [12] 18:8,17 19:8 26:8 40:18
72:1 116:2 120:20 135:4 144:10175:19 282:14
RNA-dependent [1] 19:8
RNAs [3] 25:10,12 136:12
road [1] 297:6
Robert [2] 2:9 49:20
robust [7] 55:16 69:3 70:14 79:17
182:4 183:18 290:18
role [7] 8:16 29:3 32:10 54:5 55:19
69:7 185:17
Ron [1] 5:6
Ronald [1] 2:12
roof [3] 104:22 105:2,4
Room [7] 1:10 4:16 8:3,6 84:14
216:17 289:13
rotating [1] 9:18
roughly [1] 18:2
route [2] 112:3 254:16
routine [2] 24:5 137:6
routinely [1] 277:18
rsistance [1] 105:20
rule [2] 45:21 71:13
rules[7]
38:16 39:15,18,20 41:7,10 70:18
run [3] 188:17 300:14 312:16
running [1] 152:7
RVR [5] 123:7,21 130:8 165:8 240:
18
RVR4 [5] 123:14 130:13 134:21
139:19 140:16
Ryan [2] 88:15 89:3
SSAE [2] 82:1 83:2
SAEs [1] 204:6
safe [6] 50:21 83:4 154:6 163:12
229:5,13
safely [2] 268:21 269:8safer [2] 209:4 249:1
safety [59] 24:9 80:14 91:8 93:1 96:
7,9,9,18,20 98:6 104:11 109:12
130:18 132:18 134:20 143:10 145:
8 150:7,11 177:5 179:19 197:21
198:2 205:22 206:2,5 210:7 212:
13,21 214:3,8 224:13 225:10,22
226:12 228:5,11 232:18 233:2
246:22 249:14 263:18,20 264:1,1
267:20 271:6,13 274:2,5 275:3
285:22 288:10,16 290:11 292:9
296:22 298:4 301:19
sake [3] 91:17 227:3 235:19
salient [2] 108:6 310:8
salt [1] 107:11
salutary [1] 153:8
salvage [1] 102:18
same [52] 17:3 28:16 30:12 33:8,
17,20 69:20 71:14 80:17 92:1,2
95:14 104:20 112:22 115:22 122:
15 128:6 142:22 155:20 156:15
157:6 158:22 163:8 164:17 175:4
201:12 202:8 208:13 220:8 221:
15 230:19 232:5 249:15 251:3
252:17,18,20 253:2 255:12 262:3
271:18 279:19,21 287:3 290:15
299:12,19 300:1,2,4 301:6,9
sample [6] 42:21 121:9 303:9,15,
21 305:2samples [2] 34:15,16
sampling [13] 40:8 42:10,10,12
122:6 125:21 138:11 139:17 156:
6 164:13,15 166:6 210:5
San [1] 5:12
Santa [1] 123:2
satisfied [7] 133:16 156:20 157:1
208:22 216:12 226:4 263:6
save [1] 261:11
saved [1] 261:8
saw [6] 36:20 52:20 54:13 127:18
140:22 169:10
Sheet 22 reluctant - saw
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 23/28
saying [21] 40:17 44:7 104:15,20
107:3 121:22 127:19 177:20 199:
21 209:12 225:3,16 254:8,14 271:
14 275:2 294:4 295:11 296:14
302:15 305:5
says [3] 103:1 226:8 306:8
saysB-the [1] 149:6
Sc.D [1] 2:5
scar [2] 47:6 67:1
scenario [2] 262:1 276:6
scheduled[1]
4:13schema [1] 20:2
scheme [1] 19:16
Schering [4] 174:2,4 179:13 291:
15
Schiffman [1] 148:14
School [1] 5:20schoolB-the [1] 290:19
science [1] 190:21
scientific [2] 86:21 146:1
scope [1] 12:13
score [12] 79:20 125:6 129:8 146:
7,8 204:9,11 278:22 279:2,3,7
280:4
scores [2] 145:21 225:6
scoring [1] 128:13screen [2] 53:10 76:18
screened [2] 7:11 23:12
screening [6] 23:21 24:5,6 25:6
26:16 53:18
se [1] 160:6
seats [1] 258:1
Seattle [1] 4:21
second [21] 32:17 33:15 35:10 45:
12 54:12 58:6 76:10 79:18 107:10
150:6 158:18 163:18 183:22 184:
12 193:21 198:20 202:13 230:8
274:14 279:15 283:12
second-string [1] 200:9
secondary[7]
82:8 120:14 125:16,19 126:21 140:3 166:20
section [1] 196:18
see [81] 4:18 17:16 18:2 19:11 20:
15,19 25:19 26:4 31:5,17 33:6,19
34:16 37:22 42:16 47:18 48:16 50:
18 53:10,20 54:1,19 58:6 61:1 71:
11,19,22 73:18,19 106:13 108:1,
15 110:5 115:8,19 131:1 137:11
142:10 148:18 153:13 155:2 168:
9 172:8 176:12 183:17 184:11
197:5,19 202:5,10 204:1 206:5
208:11 209:8 210:4 213:9,10 214:
12 216:2,17 218:12 224:15 227:
11 228:3,15 232:3,4 254:8 255:10,
21 260:9 266:10 270:2 279:10285:18 286:5 290:21 291:3 305:
19 312:9,22
Seef [46] 2:18 5:17,17 147:8,10
152:1 167:3,20,22 198:7,8,20 202:
14,19,22 203:10 219:17,18 222:15
223:5,18 230:17,18 233:16,18
237:2,3 239:17,18 247:7 248:7
255:1,2 256:2 273:14 283:3,4 284:
14,22 293:20 295:19,22 297:7
306:6,7 310:14
seeing [2] 135:22 150:19
seeking [3] 12:3 77:13 250:12
seem [4] 29:2 128:4 240:16 285:
21
seems [12] 32:13 39:3 111:10 126:
19 212:10 230:1 250:16 256:8
257:10,18 273:3 298:14
seen [16] 20:22 28:16 53:5 57:21
66:21 74:6 104:16 114:16 119:9
137:5 151:22 241:17 271:20 272:
12 287:3 310:11
sees[2]
45:14 53:15segments [1] 51:22
segregated [1] 74:22
segue [1] 106:10
select [3] 12:22 84:9 279:5
selected [2] 194:11 204:1
selection [4] 51:18 78:14 82:19
242:14
semi-normal [1] 47:1
Senate [1] 89:5
senescent [1] 32:10
sense [20] 41:4 75:14 90:9 98:21
145:9 160:4 162:8 165:9,21 166:9
178:5 221:9 234:18 238:6 245:9
256:13 257:3 267:16 268:20 270:
1sensitive [7] 25:9 34:22 86:17
112:12 124:10 144:22 192:22
sensitivities [1] 41:22
sensitivity [1] 25:7
sent [1] 12:16
separate [12] 87:17 112:11 192:19
212:21 213:6 224:8 237:1 249:7
279:12 280:22 302:21 306:11
separated [2] 237:19 302:21
separately [3] 192:4 225:8 258:18
separation [1] 303:2
seque [1] 305:17
sequence [3] 19:16 25:15 212:3
sequential[1]
169:15serial [1] 102:6
series [5] 67:11 168:14 197:2 203:
1 254:2
serious [9] 76:20 88:4 145:11 167:
13 175:1 199:16,17 200:14 230:
20
seriously [5] 88:8 91:5 92:12 214:
1 231:19
serotype [1] 18:11
serum [6] 32:6 58:4 61:16 63:13
129:14 183:11
serve [3] 13:22 17:1 18:22
served [2] 180:13 186:19
Service [1] 9:20
SERVICES [1] 1:1SESSION [3] 1:5 172:15 227:3
set [13] 31:15 55:9 56:9 84:6 94:10
104:9 105:19 147:10 154:9 204:
13 242:6 287:6 290:3
sets [2] 68:19 251:22
setting [16] 41:8 50:6 150:20 160:
19 165:15 166:9 169:10 183:3,4,9
186:6 206:11 210:6 267:12 276:
18 277:19
settings [1] 161:1
seven [6] 26:7 148:4 175:17 176:2
182:20 291:7
several [6] 34:11 57:12 72:20 168:17 171:6 274:19
severe [7] 81:1 83:1 112:4 150:9
151:18 286:14 300:7
severely [1] 153:17
severity [8] 29:3 46:15 127:6 218:
2 285:14 286:10 298:11,14
sex [2] 24:10,10
shame [1] 179:2
share[6]
105:10 139:21 157:2 209:19 230:11 271:22
sharply [1] 128:7
Shering [1] 3:28
Sherman [177] 2:2 3:3,13 4:3 6:11
7:20 9:9,22 10:8 11:6 15:12 16:1,
4,16 52:21 54:12 58:9 68:22 83:
15 84:6 106:3,6 142:6 143:17 147:
9 150:6,11 151:20 153:2 155:4
156:7 157:8 158:1,9 159:3 160:15
162:20 164:12 165:22 166:5 167:
20 168:12 169:13 171:1,16 174:
11 180:2,4 183:7 186:10,15 190:
16 196:17 198:7,18 202:12,15,21
203:6,14 205:5,9 206:17 207:15
208:7,17,19 209:18 211:3,12,20212:15 213:11 215:9,11 216:6,16
217:3 218:5 219:17 221:19 223:
20 225:12 226:16 227:22 229:8,
20 230:17 232:7 234:9,20 236:16
237:1 238:2 239:9,17 240:9 241:3
242:8 243:7,22 245:12,22 246:14
247:1 248:1,9,16 249:8 250:6,9,
15 251:9,12 252:15,19 253:12
255:1,20 256:7 257:4,9 258:5 260:
14 261:17 262:17 263:10 265:2,
12,16 266:6 267:3 268:1,6 269:11,
21 270:1,6,8,22 271:4,10,18 273:3,
18 276:22 278:5,18 281:5 283:2
284:4 285:11 288:2,7,11 291:12,18 292:3,15 298:8 300:11,19 301:
16 302:18 303:16 304:5,8 305:9,
16 306:6 307:14 308:5,22 310:6,
20 311:14 312:21
Sherman=s [5] 57:22 58:14 83:8
161:17 180:19
shooting [1] 104:3
shopping [1] 206:19
short [17] 37:18 38:12 40:11 45:18
50:3 67:5 68:16 96:18 107:20 119:
13 135:9 160:18 161:4 166:6 205:
2 240:18 282:17
short-term [2] 79:21 243:2
shorten [3] 184:16 252:10,12
shortened [2] 229:7 255:3shortening [2] 251:19 252:11
shorter [9] 14:17 131:12,14 139:7,
9 157:21 168:22 169:4 264:7
shortest [1] 163:14
shot [6] 104:22 105:2,4 119:6,7
139:16
shouldn=t [7] 248:11 257:1 270:
12 281:22 304:2 309:17 312:2
show [27] 10:15 11:22 26:20 34:9,
19 35:10 46:22 60:9 66:6,9 68:17
72:11 73:7 89:20 120:17 165:1
174:10 227:5,17,18 229:11 238:8
248:21,22 256:15 264:6 302:12
showed [10] 22:4 31:16 40:7 41:9
42:6 48:14 59:17 167:7 217:3 269:
6
showing [6] 36:11 41:3 60:13 136:
14 252:13 288:10
shown [26] 17:22 21:21 44:21 54:
12 55:2 59:9 60:9 62:19 65:6,12
69:2,13,15 71:5,10 73:16 108:21
109:1 123:6 144:14 168:22 175:14 184:8 254:12,13 286:15
shows [8] 21:15 34:19 40:14 70:
12 146:5 181:19 229:13 275:7
showsB-we [1] 146:2
Shreveport [2] 5:7,8
shunting [1] 204:22
shut [1] 31:8
sick [2] 150:18 189:19
side [13] 123:15 153:9 163:13 196:
1 200:2 203:20 209:8 213:12 222:
1 255:15 290:15,20,20
sign [2] 172:4 173:17
signal [2] 25:11 305:20signaling [2] 59:13 72:13
signature [1] 56:10signed [4] 171:7,20 173:18 186:11
significance [1] 21:1
significant [10] 17:17 22:9 33:10
67:4 71:10,11 129:6 147:16,22
238:19
significantly [2] 34:6 169:22
signs [2] 48:2 229:11
silence [1] 127:9
silent [1] 127:11
Silver [1] 1:11
similar [13] 14:16 28:16 37:1 41:1,
4 78:8 80:18 81:8 83:10 161:5
186:6 256:1 270:8
similarly[5]
25:12 26:11 37:3 276:22 290:21
simple [2] 164:17 238:11
simplified [1] 28:8
simplifying [1] 235:19
simplistic [1] 218:11
simply [6] 30:8 39:6 154:16 165:
16 176:10 255:13
simulate [1] 59:11
simultaneous [1] 244:13
simultaneously [4] 45:15 187:18
278:7 300:14
since [17] 16:5 51:12 79:7 85:15
113:2 143:11 155:18 159:1 163:
22 174:5 191:5 198:4 220:22 246:
8 247:10 256:14 271:14single [7] 51:14 179:9 202:17 242:
13 257:14 275:17 281:13
single-agent [4] 179:6 209:9 235:
6 238:16
single-arm [1] 239:14
single-stranded [1] 18:8
sirolomus [1] 278:1
sit [1] 186:20
site [2] 18:18 144:11
sites [1] 57:13
sitting [2] 95:7 214:2
Sheet 23 saying - sitting
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 24/28
situation [5] 31:13 87:13 88:6 214:
19 219:9
situations [1] 137:6
six [15] 20:2 26:14 27:7 42:21 54:
14 84:15 87:1,8 92:14 108:2 110:
10 149:5 175:18 187:3 252:20
size [4] 218:7 303:9,21 305:2
sizes [2] 213:8 303:15
skepticism [1] 230:11
skews [1] 60:15
skip[1]
112:7slap [1] 240:1
sleep.@ [1] 49:22
Slide [165] 10:14 11:3,8,21,22 12:
12 13:4,19 14:6,8 15:2,9 16:17 17:
5,14,20 18:6,15 19:3,18 20:14 21:
5,13 22:2,3,15 23:10 24:3,21 25:
16 26:18 27:13 28:11 29:8,18 30:
3,18 31:11 33:1 35:3,15 36:2,7,15
37:17 38:4,14 40:13,22 41:6 43:5
44:18,20 45:19 46:9,20 47:22 48:
8,20 49:3,9,18 50:16 51:6 52:6 53:
8,9 54:10,13 55:6,18 57:4,11,20,
21 58:2 59:2,17,18 60:4,20 61:7,
22 62:6,18 63:8 64:17 66:4,16 68:
20 70:6,7,19 71:16 72:18 73:1274:1,9,16 75:13 77:2 78:1,9,19 80:
8,19 81:9 82:14 83:8 84:2,10 86:3
88:15 89:13 90:17 96:5 98:8 99:
10,13 100:3 102:1,22 103:1,22
105:21 106:12 107:16 108:8 109:
6,20 110:2 111:5 113:4 114:5,17
115:11 116:11 118:4,22 119:22
120:16 122:18 124:15 125:15,22
127:8 128:11 129:17 131:9,17
132:3 133:5,8 134:3 135:1,13 136:
22 137:13 138:13 139:10 140:12
141:8,9 156:17 174:11
slide-Bwe [1] 145:20
slides[5]
21:15 52:20 66:21 92:1394:13
slightly [1] 23:7
slope [10] 31:22 32:11 33:15 36:12
58:4,6,7,11 164:17 184:15
slow [2] 27:11 263:5
slower [1] 124:9
slowing [1] 126:17
slowly [2] 46:1 286:9
small [11] 20:10 29:22 42:9 65:12
84:14 153:22 160:18 241:12 246:
16 296:22 300:4
smaller [6] 225:22 226:7 263:18
264:5,22 288:17
smallerB-the [1] 222:1
sNDA [1] 180:14so-called [2] 134:1 235:17
societal [4] 48:18 49:6,16 276:10
society [1] 16:20
socioeconomic [1] 194:16
softer [1] 99:19
sold [1] 234:18
sole [2] 26:16 253:19
solely [4] 61:4 71:1 159:17 161:19
solicit [1] 118:3
solid [1] 136:21
someB-again [1] 119:14
somebody [4] 218:7 219:11 239:
12 240:17
somehow [4] 199:2 230:19 237:
14 272:2
someone [9] 146:19 197:15,21
212:5,6 221:10 240:21 248:10,13
sometimes [2] 42:20 156:2
somewhat [5] 42:3 107:12 116:17
119:10 155:18
somewhere [1] 199:10
soon[8]
103:20 139:15 207:3 220:17 221:14 228:5 229:3 231:20
sooner [1] 299:4
sophisticated [1] 62:1
sorry [2] 107:18 202:15
sort [12] 32:21 39:16 59:21 104:2
106:10 137:4 163:7 209:2 215:1
252:7 266:19,22
soul [2] 119:19 129:13soul=s [1] 127:21
sounded [1] 156:20
sounds [1] 225:15
source [1] 121:10
sources [2] 88:19 258:9
Southeast [1] 20:18
Southern [2] 190:17 191:3Southwest [1] 204:10
speaker [5] 83:16 172:6,19 180:3
190:16
speakers [3] 142:12 173:18 191:
15
speaking [5] 4:8 52:1 95:6 173:11
286:8
speaks [1] 164:2
special [19] 7:18 52:14 75:12 76:
13 78:10 135:11 141:5,15 195:6
222:6 226:1 229:11 230:3 263:21
270:20 276:13 284:20 289:4 297:
4
species[1]
19:12Specific [27] 8:1 29:22 48:21 56:5
59:22 60:2 159:13 161:1 171:8
182:12 188:1 196:19 204:3 207:
16 229:14 233:7 240:10 243:8
246:19 247:4 251:11 252:9 257:
10 258:14 275:6 304:5 311:22
Specifically [9] 13:5 181:11 188:9
207:21 248:17 250:18 272:11 284:
18 306:13
specifications [1] 111:4
specificity [2] 25:7 125:20
specifics [1] 159:17
specified [1] 133:13
specimens [2] 67:10,11
spectrum [3] 111:21 147:20 275:4speculate [1] 158:11
speculating [1] 159:8
speculation [2] 91:17 161:8
speed [1] 298:6
spell [1] 173:13
spend [1] 112:19
spent [1] 84:15
spinning [1] 193:10
spirit [2] 161:7 180:6
spoke [1] 198:22
spoken [2] 106:1 127:10
sponsors [5] 7:9 12:4 95:21 155:
22 306:2
spontaneous [3] 53:11 108:20
286:17
spontaneously [2] 55:17 56:22
Spot [1] 181:19
Spring [1] 1:11
spur [1] 191:7
squirming [1] 258:1
stability [1] 27:7
stable[1]
189:9STAFF [2] 2:21 9:8
stage [21] 50:6 54:4 67:3,13 69:9
101:14 111:7 113:9 125:5 154:9
167:5,11,11,12,12 197:8 202:16
203:15 211:21 243:4 268:9
stages [9] 32:13 45:10 47:14 69:9
153:19 189:1 203:17 214:10 246:
10
staggering [1] 158:6
stain [1] 47:4
stalking [1] 144:7
stance [2] 210:14 262:19
stand [2] 92:18 93:20
standard [77] 11:12,14,17 13:21
14:11 36:5 40:2 51:12 59:6 64:570:5 73:14 75:9 76:3 77:8 85:19
86:1 94:13 101:13 103:3,7 109:7
111:17 113:3 118:11 129:21 130:
20 131:4,11,21 132:2,15 134:7,8,
18 139:4 140:15,21 143:2,7,10,15
147:6 148:22 149:3,21 156:18
157:2 166:16 169:10 189:14 201:
18 203:18 207:22 209:11,13 240:
19 242:2 252:11,20 253:5 262:7
264:17 269:7 275:5,9,12,13,16
276:19 278:16 287:8,11,12,13,16
292:22
standards [2] 189:18 217:16
standpoint[5]
66:6 236:7 242:10252:3,8
stands [1] 232:8
star [1] 57:13
stark [1] 182:9
start [30] 4:19 17:6 33:4 44:5 79:
10 97:4,6,11 110:4 136:14 142:9,
14,18 158:6,7 173:19 180:21 186:
12 195:22 196:9,21 197:7 203:8
212:4 214:11 233:18 251:4 258:
16,21 261:20
started [5] 85:2 92:11,12 106:6
233:8
starting [7] 16:7 31:16 33:8,19
110:4 169:20 193:2
starts [3] 45:12 54:11 121:9STAT [1] 59:12
state [23] 28:19,21 29:10,14,16,17
30:2 43:14 53:6,14,19 80:4 144:5
151:9 162:5 173:19 219:4,7,12
274:6 279:8 282:17 283:17
stated [5] 199:10 216:20 259:1
262:19 281:15
Statement [13] 3:5 6:12,13 9:7
171:18 172:10,20 173:6,10,15
194:7 211:5 269:5
States [12] 17:16,22 20:18 22:8 74:
14 79:2 97:20 113:12 208:14 245:
19 280:9 304:1
statistical [1] 156:10
statistically [3] 71:10,11 245:16
statistician [2] 5:20 213:1
statistics [1] 155:17
status [1] 153:15
staunch [1] 112:10
STDs [1] 24:9
steady [9] 24:10 28:19,21 29:10,
14,16,16 30:1 43:13steatosis [1] 46:5
steeper [1] 36:11
stellate [1] 53:2
stems [1] 12:15
step [3] 17:12 95:3 207:19
stepped [1] 177:20
steps [1] 50:18
Stewart [1] 26:19
still [30] 17:11 24:12 27:17 44:13
49:21 55:14 58:16,18 62:17 63:21
66:1 73:18 78:11 88:22 102:17
124:19 145:3,4 147:12 167:14
231:13 243:19 266:3,5 275:2 292:
22 293:11 299:19 301:12 303:7
stimulates [1] 60:13stimulatory [1] 60:11
stop [10] 40:21 41:14 64:2 131:1
179:1,5 213:10 220:7 295:16 296:
8
stopped [3] 30:4 32:4 76:7
stopping [7] 37:22 38:16 70:18
156:22 157:2 162:10 166:21
stops [1] 121:8
story [2] 116:14 247:10
STR [1] 74:11
straight [2] 4:15 33:12
straightforward [3] 126:20 157:
11 222:10
strain-specific[1]
251:7strand [1] 18:8
strata [8] 201:3 302:8,8,9,12,13,14,
16
strategies [6] 109:18 163:6 174:
15 257:7,16 282:21
strategize [1] 145:12
strategy [3] 145:14 153:7 206:11
stratification [6] 265:8 266:2,12
267:15 303:8 307:16
stratifications [1] 311:21
stratified [4] 76:1 213:2,6 237:15
stratify [3] 75:19 201:19 246:11
stratum [2] 265:8 268:3
stream [1] 57:1
street [2] 158:20 213:13stress [1] 261:1
strict [1] 41:12
strong [3] 78:15 232:21 301:17
strongly [9] 80:13 87:14 91:2 179:
14 187:16 188:12 196:22 229:2
244:12
structural [3] 18:19 55:10 61:1structure [1] 25:14
structure-function [1] 250:19
struggling [1] 219:18
stubborn [2] 183:21 184:12
Sheet 24 situation - stubborn
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 25/28
studied [17] 12:19 111:11,15 115:
8 137:22 157:21 169:14 197:11
206:2 211:16 220:9 225:18 242:1
264:21 277:17 281:1 311:8
studies [160] 12:20 23:4 27:9 32:
20 37:4 47:11 51:10 66:9,12 72:9,
17 73:7,14,15 92:12,17,19 94:5,12
96:8,9,10,10,11,13,16,17 97:5,16
103:10,12,16 105:17,18 114:14
128:9 131:21 133:11,17 134:13
137:8 141:20 153:4 157:4 158:5,7167:14 168:8,14,17 175:16 177:
16,21 178:18 187:19 194:10 195:
1 197:10,17 199:8 200:9 203:1,22
204:1,13 206:9,12 207:17,20 209:
17 213:6,7 216:1,3,18 217:20 218:
14 220:7,10,19 222:2,13,22 226:8
227:10,12 229:17 230:3,13 231:1
232:5 233:3,5,8 237:17 241:18
243:2 248:19 253:10,11,14 254:6,
15 256:9,11,17,17 257:19,20 260:
16 261:6,14,20,21 262:16 264:5,
22 267:18 268:9,10 270:10,19
272:5 273:4 274:3 277:2 278:6
281:14 283:7,14,16 284:11 285:1
289:16 291:15 295:16,21 296:12,15 297:3,4 299:1,3,13 301:18 302:
22,22 303:10,11 304:21 305:21
306:1,3,12 307:18,22 308:9,9,14,
14
studies= [1] 261:1
studies@ [1] 296:18
studiesB-I [1] 265:9study [109] 7:4 14:4 22:19 46:10
51:17 69:19 71:22 75:17 77:4 84:
20 88:7 98:9,15 100:1 101:20 105:
7,11,12 111:6 115:1 127:17,18,19
128:4 129:18,20 144:13 145:15
147:12 148:3,4 149:6,7,17 150:13,
14,18 152:2,6,8,12,21 154:13 167:9,18,22 180:11 187:7,17,21 188:6,
9,19 189:10 200:21 204:16,18
208:5,22 209:1,9 211:9,18,18 212:
7 213:2 214:5 215:6,15 216:2 217:
19 218:19 225:9,20 227:5 228:3,7
236:8 239:13,14 241:5,14 248:14
251:1 253:8 255:11 264:4,8,16
265:11 266:5 267:17 274:9 276:
15 278:2,15 280:22 291:16 293:2
294:22,22 295:2 296:3 305:4 307:
4 308:16 310:7,10 311:19
studying [2] 140:14 205:2
stuff [1] 34:8
sub-specialists [1] 289:20
subcutaneously [1] 291:11subgroup [7] 81:3 193:19 259:12,
20 289:7 294:15 295:14
subgroups [17] 11:18 13:18 23:4
197:2 246:13 269:19 284:7,20
288:17,19,20 289:4 294:8,11,13
295:13 308:1
subject [6] 14:15 55:21 77:15 94:4
157:10 228:8
subjecting [1] 240:21
subjects [3] 13:10 16:22 272:12
submit [3] 191:10 217:18 218:21
submitted [1] 107:14
submitting [1] 8:5
suboptimal [1] 179:8subpopulation [1] 72:21
subpopulations [4] 87:20 88:9
263:19 298:1
subsequent [1] 144:17
subsequently [3] 152:21 168:20
170:21
subset [4] 45:6 72:9 179:3 227:9
substance[2]
99:3,4substantial [2] 138:15 304:20
substantiated [1] 129:11
substitutes [2] 79:14 81:4
substituting [3] 132:10 254:1 255:
9
substitution [7] 14:20 132:4 140:
18 253:10,14 256:16 257:7
substitutions [1] 275:18
substudies [3] 193:6 195:16 270:
19
substudy [1] 213:8
subtract [2] 253:5,6
subtype [1] 20:13
subvert [1] 61:3
succeed [1] 217:8success [5] 83:10,12 119:6 125:
13 262:5
successful [4] 141:2 229:19 279:
20 282:21
successfully [1] 312:16
sudden [1] 308:16
sufficient [9] 65:22 137:20 213:9
269:12 303:21 305:2,14 308:19,
20
suggest [11] 22:13 27:10 83:11 97:
5,7 103:11 104:7 105:7 129:13
144:13 269:9
suggested [14] 43:11 97:13 114:
13 123:6,12 125:10 132:21 141:22 156:17 170:3 226:4 236:5 238:
16 262:14
suggesting [11] 22:17 36:13 37:2
49:13 221:1 241:6 265:12 269:11
270:2,18 293:22
suggestion [1] 192:16
suggestions [2] 40:6 130:7
suggests [5] 18:9 19:5 58:21 133:
19 245:5
sum [3] 257:9 301:16 302:6
summarize [5] 13:2 15:18 108:5
197:6 232:7
summarized [1] 275:1
summarizing [1] 51:8
Summary [5] 3:23 106:7,14 108:1181:3
summation [1] 268:7
Sun [7] 2:10 5:22,22 8:14,19 218:5,
6
Sun=s [2] 8:16 246:2
superb [1] 228:10
superior [1] 262:6
superiority [4] 79:6 238:8 252:5
257:8
support [7] 88:17 129:16 135:9
179:14 207:17 226:17 249:10
supportable [1] 253:7
supported [1] 129:11
supportive [1] 270:16
supportiveB-very [1] 270:16
suppose [4] 159:7 163:2 209:12
210:9
suppresion [1] 125:12
suppress [3] 124:17,18 161:12
suppressed [1] 162:11
suppresses [1] 272:2
suppression[10]
120:11 124:16137:7 140:5,6 141:20 150:12 162:
14 175:12 196:5
surely [1] 283:15
surprised [1] 312:9
surprising [1] 183:17
surrogate [4] 53:19 61:15 120:7
121:3
surrogate-Bit [1] 53:18
surrogately [1] 70:4
surrounded [1] 47:5
surrounding [2] 186:7 190:11
survey [1] 154:15
survival [6] 72:21 80:2 126:12 146:4,6 153:21
survive [1] 188:7suspect [5] 151:9 159:10 169:3
199:21 302:2
suspected [1] 36:20
sustained [18] 37:16 51:12 58:19
63:11 64:3 101:6 117:19 120:18
160:1,2,9 161:11,14,15 175:15,18
227:8 238:18
SVR [70] 11:15 39:13 62:5 64:6,18
65:22 69:2,3 70:15 71:5,19 73:19
77:20,22 80:3 101:21 104:2 118:1
120:10,18 121:2,10,16,17,21 122:
1,5,10,14,20,21 123:2,14,16,21
127:16,21 128:1,4,5,8,12 135:15,
17 136:20 137:2 139:11,11,11141:9,13,17 143:22 144:20 147:1
156:21 158:12,13 159:10,11 160:
12 161:19 165:11,13,15,18 184:4
195:11 253:3 279:9
SVR12 [1] 15:6
SVRs [2] 64:15 143:1
swallow [1] 291:8
Swan [20] 2:17 5:4,4 197:15,16
211:13 212:2 234:10 240:9,10
259:5 260:14,15 266:6,7 271:10,
11 305:9,17 312:7
swinging [1] 163:7
switch [1] 163:10
switching [1] 56:8
sympathetic [1] 217:15symptoms [2] 25:21 48:2
synergistic [1] 132:19
synthesis [1] 62:11
synthesize [1] 105:3
synthetic [3] 79:22 110:21 204:20
syphilis [1] 82:22
system [7] 4:9 60:6,7 176:11 183:
1 227:16 228:21
systems [2] 67:2 128:13
TT-alpha-1 [1] 56:7
T-alpha-2 [1] 56:8
T-cell [1] 181:20T-helper [3] 55:12,20 56:2
T-helper-1 [4] 56:11 60:8,16 62:
22
T-helper-2 [1] 63:2
T-lymphocyte [1] 57:7
T-regulatory [1] 56:4
t.i.d [1] 266:20
table [3] 8:3 84:6 310:22
take-Beven[1]
249:14takeB-if [1] 231:9
Talal [1] 42:5talked [8] 66:5 68:21 175:7 177:13
178:1 235:16 241:7 274:1
talks [2] 88:13 190:20
target [8] 25:11 55:5 225:20 282:2,
19 283:1 303:15 311:17
targeted [4] 213:8 250:21 257:12
263:2
targeting [1] 184:9
targets [3] 19:1 250:20 276:16
targetsB-to [1] 196:7
task [4] 90:8 92:16 106:10 196:10
tAttAt [1] 85:12
tattooing [1] 24:19tau-like [1] 12:10
Tauber [17] 2:24 3:24 6:5,5 13:2
15:17 106:9 144:1 145:19 150:11
154:9,14 155:5,16 156:15 178:10
198:22
Tauber=s [1] 181:3
teams [1] 180:13
technique [2] 67:17,20
techniques [1] 145:1
technology [4] 117:9 120:8 123:9
135:18
teeth [1] 226:10
tempered [1] 205:19
temporary[1]
277:13temptation [1] 78:6
ten [4] 85:18 101:9 141:12 172:1
ten-fold [1] 54:2
tend [5] 98:21 175:21 176:12 187:
13 286:13
tendency [1] 267:6
tends [2] 21:19 187:8
tenofovir [2] 272:10,17
term [4] 80:3 163:1 222:2 293:15
terminate [4] 68:5 161:10,13,19
terminated [1] 167:22
terminates [1] 63:19
terminating [1] 51:1
termination [6] 58:5 59:15 79:18
154:6 162:15 170:16terminology [1] 28:12
terms [45] 17:8,9 23:21 40:10 41:
12,20 46:6 48:12,17 64:13 66:2
73:19 79:14 86:16 96:17 97:14 99:
11,14,17,17 104:1,5 112:2 139:4
143:13,22 144:13 145:15 156:10
162:4 166:17 168:22 191:19 194:
4 228:5 251:19 252:1 253:2,3,15
267:8,16 275:3 279:12 308:18
terrible [2] 231:4 288:21
terribly [3] 55:1 220:22 241:15
Sheet 25 studied - terribly
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 26/28
terrific [2] 231:8,18
test [6] 25:6 41:22 54:8 70:11 132:
19 181:19
tested [3] 38:12 44:12 151:22
testing [5] 24:14 26:4 163:15 193:
1 247:3
tests [8] 24:22 25:2,6 26:6 54:7
101:15,19,22
Texas [1] 16:15
text [1] 86:18
Th1[1]
56:21Thanks [2] 83:22 261:16
that=s [1] 37:7
theme [1] 122:9
themes [1] 118:17
themselves [3] 58:12 100:11 287:
7
theoretically [1] 33:9
theory [1] 63:22
Therapeutic [8] 3:15 50:13,19 51:
18 55:21 181:12 182:18 278:11
therapeutically [1] 56:19
therapies [28] 40:3 69:16 70:20
77:13 82:20 150:8 175:9,14 178:4
180:21 181:2,10 182:21 183:6,7
184:6,21 185:1,9,10 186:8 207:7,13 209:14 214:17 217:19 254:3
266:11
therapy [102] 14:2,2 29:4 34:18 37:
3 39:12,14 51:13 57:1 58:2 63:9,
20 64:2,5,16 65:3,4,13,20 68:10,
17,17 70:5,10,11,18 71:9 73:3,6
76:8 79:1 81:22 82:19 83:5 93:17
98:17 100:15 102:18 109:11,12
116:8 143:13 145:2 151:1 153:14,
17 159:10,13,14 160:2,9 161:2,10
166:14,16,16 168:18,22 169:15
170:22 176:9,17 177:11 179:6,8
180:8 182:14 183:12 186:1 192:1,
20 196:1,9 205:3 208:3 212:4 213:16 214:11 217:9 235:7 238:17
240:3 252:22 253:18 259:11,13,
15,17,18,20 260:2,7 262:6 267:21
275:9,11,14 276:16 279:20 280:
10 282:5,18
thereafter [1] 228:6
thereby [2] 184:13 242:6
Therefore [17] 35:12 53:6 61:15
133:10 138:2 146:9 188:8 189:6
199:5 207:7 215:13 217:19 219:2
265:20 279:17 289:18 306:20
thinking [7] 92:10 214:3 215:5
253:13,15 258:22 307:2
third [7] 26:7 32:19 130:2 132:1
140:14 199:3 279:14this-Bthat [1] 146:3
thisB-12-week [1] 40:1
though [14] 11:16 25:2 26:5 103:
13 125:14 150:17,21 157:15 160:
16 233:6 257:18 268:22 276:22
302:2
thoughtful [2] 233:17 259:8thoughts [4] 81:18 211:21 222:17
235:10
Thousands [1] 215:9
three [34] 9:20 10:19 13:11 54:17
65:21 66:14 75:20 76:12 85:1,20
86:1,4 101:6 103:2 104:1 125:3
130:19,22 136:13 141:14 160:10
167:4,6 175:22 236:3 237:19 241:
12 292:11,11 303:20,22 304:1
305:4 307:16
threshold [1] 129:9
threw [1] 164:22
through-BI [1] 301:21throughout [1] 202:7
throw[3]
158:10 227:4 272:14Thursday [1] 1:7
tied [1] 39:2
tight [1] 41:20
till [3] 88:20 154:13 270:13timely [3] 96:14 205:17 300:10
timing [4] 15:6 68:2 121:17 139:14
tired [1] 176:3
tissue [2] 63:1 67:19
tissues [2] 18:14 52:12
title [2] 106:13,15
to.@ [1] 270:15
today [29] 12:1,6,14 15:19,21 17:2
47:13 84:1,4,5 85:22 89:14 90:5
92:11,18 95:6 97:17 99:3,8 106:
22 107:3,6 180:18 181:5 187:7188:18 195:19 257:1 309:4
today=s [5] 7:8,21 8:3 9:16 15:11
together [4] 35:21 105:10 112:16
241:13
tolerability [6] 81:16 251:14,18,19
252:1,7
tolerance [2] 175:5 275:13
tolerate [2] 70:21 150:20
tolerated [5] 73:22 119:2 174:22
290:17,22
tolerating [1] 290:18
Tom [1] 297:8
tomorrow [3] 15:21 312:4,22
tomorrow=s[1]
15:11tonight [1] 237:21
took [3] 128:8 224:19 239:2
tool [2] 67:8 182:18tools [5] 44:9 123:22 139:19,20
140:1
top [5] 75:6 76:15 110:12 207:22
261:4
topic [6] 7:8,12 9:16 10:13 173:1
294:12
topics [1] 7:13
total [6] 24:13 31:7 120:10 172:6
237:12 283:4
totally [1] 162:21
touched [2] 98:10 112:18
tough [1] 251:17tougher [1] 73:16
toward [1] 81:12
towards [5] 42:8 153:21 199:16
264:9 267:6
toxicities [6] 81:2 222:3,6 223:17
224:18 293:11
toxicity [16] 11:19 94:19,20 131:15
132:18 176:18 189:12,16 206:8
210:11 241:8,8,9,11 263:21 265:1
Tracey [1] 2:17
track [7] 85:13 91:3 93:9,13 100:5
104:6 228:11
tract [1] 67:19
tracts [1] 67:13
Tracy [14] 5:4 197:15 199:21 211:
12 234:9 240:9 260:14 261:19
262:14 266:6 271:10 305:9,16
312:5
tradeoff [1] 218:17
tradeoffs [1] 218:15
traditional [1] 159:11
traditionally[1]
222:22traffic [2] 86:11,15
trajectory [2] 218:3 280:5
transiently [1] 26:10
translate [3] 136:3 165:5 279:15
transparency [1] 172:14
transparent [1] 172:12
transplant [71] 21:12 45:17 71:15
74:4 80:11 88:12 93:5 109:4 115:
9 126:16,22 127:6 128:3,22 129:2
136:16 146:1,10 150:20 152:19
160:19,22 195:5 210:6,8 216:21
217:6,17 218:1 219:21 220:19
221:11,17,18 225:6 228:19 258:
10 273:10 274:4,4,7,7,13,14,16,20
275:9,11,21 276:5,8,13,17,19 277:19 278:9 279:10,14,18 280:13,14,
21 281:9,11,21 282:8 284:6,10,11,
19 296:3
transplant-free [1] 80:2
transplantation [23] 6:4 11:1 13:
13 76:17 78:21 111:22 126:11,19
127:2 128:18 146:6 152:9,16 204:
3,7 222:19 225:7 228:21 273:6,10,
16,19 280:9
transplanted [5] 74:12 127:4 146:
5 204:15 274:22
transplanters [1] 129:3
transplants [5] 74:14 213:20,22
217:2 231:22travel [1] 173:3traveled [1] 87:2
Treat [27] 3:15 39:6,6 50:13 73:16
83:7 111:20 112:13,16 130:22
134:2 143:14,14 145:10 157:18
174:14,17 220:22 222:11 242:5
249:18 262:10 283:8,19 295:7
296:10 298:16
treated [34] 26:22 34:14 36:5 41:
13 64:9 115:20 148:1,7,11,12 153:
19 178:15,21,22 199:13,22 200:6
201:17 203:13 212:22 220:16 221:
1 223:12 231:7 237:8 239:21 240:
8 259:14 268:21 269:8 287:17,18
292:17 295:1treating [10] 47:14 76:14 81:19
140:17 151:2 192:12 220:18 243:
1 274:1 278:9
Treatment [125] 3:22 5:4 6:22 14:
4 23:16 39:4,9 40:3,20 43:14 44:
17 49:12,13 63:15 64:22 65:8 73:
17 76:9 77:21 78:14 82:2,22 83:
18 86:22 88:19 100:7 106:19 109:
7,17 113:14 114:16 117:11 118:6,
14 119:9,20 121:4,8 122:15 124:3
131:1,13 134:9,11,18 136:10 137:
3,10 139:6,7,8 140:15,16,18 141:
10,18 144:21 148:12,16 149:9,12,
13 152:14 153:11 155:9,10,20
158:6 160:22 161:14 162:7 165:5
166:21 168:4 169:4 174:6,9 175:
18 182:2,7 183:10,18 184:3,16
191:14,14,20 193:1,3 194:3 196:
14 200:11,22 201:18 207:11 210:
20 232:17 233:5,22 234:2 235:9
236:1 240:16 242:20 243:13 255:
3 259:3 262:4 263:15 264:5 267:9268:4,15 272:12 273:15 279:18
280:14 287:11,20 292:6 293:1,6,8
297:10 303:13
treatment-experience [1] 233:
10
treatment-experienced [23] 14:
15 75:6 76:4 78:2 111:13 113:17
119:1,8 123:1,4,15,19 138:4 177:
9 178:2 179:21 234:3,7 236:16
241:15 244:5,17 280:20
treatment-expreienced [1] 130:
8
treatment-naive [14] 74:21 75:16
111:14 113:9 119:5 122:22 123:5,
18 125:17 130:4 138:1 177:8 269:6 270:18
treatment-race [1] 303:5
treatmentB [1] 294:20
treatments [18] 113:1 117:17 122:
11,13 131:6 135:3,16 138:17 139:
13 151:3 153:1 184:14,18 232:16
244:9 249:11 261:10 272:10
tree [3] 19:19,22 166:12
trees [1] 19:20
tremendous [2] 92:16 185:3
trespass [1] 154:20
tri-infected [1] 187:1
Trial [67] 3:14 6:20 12:18,21 14:7,
10 15:15 41:3,14 50:9,12 51:2070:17 77:16,18,21 78:6 106:18
139:1 147:13,13,15 149:9 152:7,
13 167:1 176:11 185:14 186:14
192:19 211:16 220:21 221:21 223:
15 224:6,8,10,21 225:3,11 237:6
250:4 253:19 254:7,18 259:19,20
260:8 262:2,3 263:4 267:20 268:5
269:6 278:11 281:4 282:19 289:
19 291:17 292:7 297:17 302:13
309:8 310:8,14,18 311:4
trials [63] 11:14 13:1 39:17 40:14
51:14,17,19 60:2 64:14 65:16 73:
20 77:12 79:6 80:16 81:12 114:8,
13 135:3 138:12 146:21 157:16
167:4,6 174:5 179:15 185:11 186:17 191:4 192:15 194:13 212:10
218:13 222:8 227:7,9 232:14,20,
22 241:1 243:5,16,20 244:12 259:
9 261:22 262:12 268:19,19 270:
12 271:13 277:4 281:20 287:21
288:13,14 291:13 298:5 300:13
309:2,3,13 310:12 312:16
tricky [1] 294:12
tried [1] 189:14
triglycerides [1] 104:13
trillion [2] 19:6,7
Sheet 26 terrific - trillion
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 27/28
trim [2] 67:21,22
triphosphate [1] 62:12
triply [1] 272:16
trough [3] 277:8,22 301:4
true [18] 43:15,18,18 62:19 63:3 69:
20 71:14 116:19 117:21 160:15
165:5 200:11 235:3 239:12,20
272:19 285:20 300:6
truly [5] 54:21 65:5 81:18 167:18
280:4
try[17]
76:10 84:4 95:2,13 97:3103:20 105:17 124:1 168:9 192:
16 197:6 219:11,15,16 272:11
282:8 301:20
trying [12] 121:13 145:10 152:13
163:21 224:12 243:11 248:21,22
255:4 270:4 294:5 295:22
tumors [1] 184:10
Turcotte [3] 128:16 129:1,7
turn [7] 4:8,11 63:9 74:17 129:20
196:19 277:22
turned [1] 23:17
turnover [2] 82:3 135:4
turns [1] 285:8
twelve [1] 171:4
Twenty-four [1] 64:4twice [2] 137:5 141:18
two [49] 13:11 14:21 19:10 35:4,7
37:11 51:22 56:6 81:10,12 85:11
87:15 88:16 90:18,21 94:19 101:5
113:7 116:2 119:14,17 133:6 140:
20 144:15 155:10 158:12 159:18
166:3 168:4,5,11 171:19 174:19
175:16 186:10 201:2 240:20 251:
22 266:3 273:22 278:21 290:12
291:14 292:10,11 301:5 303:19
304:1 310:8
two-day [1] 227:2
two-fold [1] 162:2
two-log[2]
40:17 70:9two-part [1] 106:15
two-plus [1] 133:21
two-thirds [2] 18:2 255:22
type [15] 32:22 35:14 36:3 70:1
125:21 166:12 169:15 182:16,17
208:4 214:21 218:16 248:9 271:5
295:17
types [11] 56:6 62:14 151:14,16
169:1 181:2 182:3 185:13,15 309:
19,20
typical [2] 25:18 27:8typically [2] 119:13 160:18
U
U.S [10] 10:16 18:3 21:8,12 22:1975:22 245:11,18 303:20 304:22
ultimate [6] 50:19 59:15 82:6 176:
16,18 224:14
ultimately [8] 30:10 56:19 80:1 83:
13 93:15 170:16 247:13,18
unable [2] 195:22 196:8
unaddressed [1] 17:11
unanimous [1] 311:16
unapproved [1] 295:3
unavoidable [1] 217:7
unbalanced [1] 228:18
unboosted [1] 301:3
unclear [2] 32:12 142:13
uncommon [1] 19:7
Unconfirmed [1] 24:16
unconscionable [1] 201:7
under [17] 14:4 63:20 65:3,13 116:
6 144:3 189:22 210:8 211:19 212:
7 270:11 286:3 287:21 288:13
291:16,17 292:10
under-represented [1] 114:11
undergo [3] 23:16 24:6 45:17
underlie[1]
58:1underlying [1] 76:21
underscore [2] 216:19 246:7
understand [31] 94:17 96:3 102:5,
10,12 109:16 113:14 114:15 156:
12 164:4,9 172:16 176:19 179:5
185:12 189:13,15 192:3 193:9
195:8 215:4 218:2,10 220:21 222:
12 224:17 227:19 229:4 242:9
303:11 311:6
understandably [1] 219:3
understanding [10] 45:7 62:17
114:9 192:7 251:5 264:18 266:7
267:11 293:12 300:4
understands [1] 94:9
understood [6] 27:18 68:14 132:7220:6 286:18 293:21
undetectability [1] 71:22
undetectable [4] 120:20 127:5
165:19 238:17
undetectableB-again [1] 123:8
undiagnosed [1] 22:10
unduly [1] 230:15
unequal [1] 113:7unequivocal [1] 217:3unequivocally [1] 146:2
unforeseen [1] 204:6
unfortunate [1] 186:22
unfortunately [4] 60:17 64:18
150:17 275:22uniform [2] 139:18 155:8
uninfected [3] 27:19 28:2 30:13
unintended [1] 181:9
unique [1] 300:5
uniqueness [1] 281:4
unit [3] 43:1 47:5 286:11
United [11] 17:16,22 20:17 22:8 74:
14 79:2 97:20 113:12 245:18 280:
9 304:1
University [6] 3:19 4:21 5:12 16:
14 190:17 191:2
unknown [2] 141:13 167:14
unless [4] 132:11 197:20 284:4
289:18
Unlike [2] 7:6 36:20unlikely [2] 39:12 40:19
unmet [3] 179:22 184:2,13
unnecessary [1] 261:6
UNOS [1] 79:4
unproven [2] 52:12 136:4
unpublished [1] 146:21
unrealistic [1] 263:5
unreasonable [1] 256:6
until [15] 30:10 38:3 95:17 103:14
115:1 151:22 232:20 239:3 256:
15 272:22 283:12,14,19 296:15
297:12
untilB-and [1] 104:19
untreated [2] 112:15 120:22
unusual [1] 98:20up [70] 4:14 9:22 10:20 12:2 17:1,3,
19 19:7 26:12 27:3 32:16 34:1 35:
19 49:1 53:5 82:15 88:20 96:21
104:9 105:19 110:5 118:19 119:3
125:9 132:21 133:13 136:14 141:
14 142:8 147:10 152:18 157:20
164:22 165:15 171:7,20 172:4173:17,18 176:8 186:6,11 199:10
200:13 201:1 203:7 206:12 212:1
213:1 214:10 215:15 220:4 221:6
226:19 228:16 229:12 245:8 248:
18 256:4 257:9 266:2 276:1 283:5,
22 297:8 299:1 301:16 302:6 303:
4 304:15
up-front [1] 262:14
up@ [1] 224:5
upcoming [1] 26:21
update [1] 167:3
updated [3] 11:7 15:13 22:3
updating [1] 21:15
upper [7] 53:12,12 63:4 110:5 304:
3 309:10,22upwards [1] 247:11
urban [1] 97:21
urge [1] 80:13
urgency [4] 73:10 228:19 266:11
300:7
urgent [2] 113:20 261:11
urging [1] 296:11
usage [2] 102:6 288:1
useful [6] 24:15 44:11 130:13 140:3 207:9 285:17
usefulness [1] 229:6
users [4] 99:2,3 312:10,16
uses [1] 37:22
using[28]
37:9 40:7 63:12 65:18118:15 120:6 123:8 130:8,13,20
133:6 144:22 147:1 155:20 158:
15 160:12 164:21 166:5 185:11
192:22 223:3 255:12 263:16 283:
18 290:12 291:10 299:14 312:15
usual [1] 152:17usurp [2] 52:4 74:19
utility [4] 66:18 93:18 101:16 182:
19
utility-Bnot [1] 101:15
utilization [4] 67:9 77:8 79:15 276:
19
utilize [1] 181:10
utilizing [1] 138:17
VVA [1] 5:7
vaccine [1] 50:21
vaccines [3] 181:12 186:4 251:8
valid [5] 136:2 146:10 176:5 245:
16 246:1
validate [1] 136:11
validated [5] 79:20 139:13,22 240:
18 261:15
validity [1] 122:15
Valley [1] 20:19
valuable [1] 211:22
value [5] 40:16 121:14 123:18 129:
12 185:13
values [1] 129:9
vantage [1] 206:14
variabilities [1] 41:16
variability [7] 27:3 41:18,21 44:14
53:16 69:1,14
variable [6] 43:21 45:21 52:21 53:
5,6 83:1
variation [1] 27:1
variations[1]
281:17variceal [2] 110:20 167:9varices [1] 45:14
variety [11] 25:10 52:9 61:2 78:4
79:5 205:13 214:7 216:22 245:20
277:2 298:22
various [8] 21:1 32:9 45:10 76:5
165:3 181:14 184:8 290:1
variously [1] 120:19
vary [1] 162:4
varying [2] 20:16 33:5
veering [1] 229:21
venous [1] 167:8
venture [1] 119:20
versus [13] 14:2 36:18 42:1 69:6
71:20 74:12 111:7,14 201:1 215:20 235:17 246:17 259:15
vertex [2] 91:16,20
vertical [1] 287:1vertically [1] 290:5
viable [5] 163:6 179:12 244:8 251:
15 255:20
vice [1] 174:1
Videx [1] 261:3
Vierling [39] 2:20 3:16 6:2,2 7:20
15:15 37:12 50:7,15 83:15 84:7
99:14 129:10 143:17,20 153:2,3
161:6,7 167:2 170:6,7 203:14,15
216:16,17 220:17 223:20,21 227:
22 228:2 246:6,7 254:15,20 273:22 277:5 278:8,20
Vierling=s [3] 112:21 116:16 180:
21
view [9] 52:3 177:15 201:8,22 221:
12 250:3 253:14,20 306:7
viewB-I [1] 306:22
viewed [1] 280:22
viewing [1] 242:10
viewpoints [1] 119:15
views [1] 198:17
vigorous [1] 55:13
Viral [99] 3:12 15:13 16:3,22 18:1627:1,2,8,11,15 28:9,12,15,19,21
29:1,5 30:5,10,21 31:18 32:22 33:
4,10,20 34:21 37:5,16 39:18,2140:5,7,11 41:9,19 42:16 43:14,20
55:15 56:1 57:16 62:14 63:13 69:
4,6,17 71:21 90:3 113:10 118:18
120:4,11 121:3 122:21 124:9,16
125:11 127:4 130:11 134:21 135:
22 140:5,6,11 144:1 153:5 158:15
162:11,22 165:9,14 166:22 169:2,
20 170:1 175:8 180:11,19,22 181:
14 183:5,10,22 184:12,21 200:2,
21 220:15 239:22 240:5 243:3
253:2 267:6,12 282:13 285:1 307:
Sheet 27 trim - Viral
8/14/2019 US Food and Drug Administration: 2006-4250T1-Index
http://slidepdf.com/reader/full/us-food-and-drug-administration-2006-4250t1-index 28/28
21 310:14,18
virally [1] 56:12
viremia [7] 54:6 127:1 128:2 144:
22 160:21 161:3 279:10
viremic [1] 279:16
virions [3] 19:6 29:15 162:1
virologic [26] 15:5 51:12 58:19 63:
11,17,17 64:3 65:4,7,18 70:8,10,
12 72:3 75:11 117:20 120:18 123:
17 161:11,15 166:14 192:1,5 193:
4 196:4 236:7virological [1] 82:7virology [1] 292:17
virtually [4] 35:8 225:7 278:9 303:
18
virtue [1] 132:17
virus [63] 18:5,7,8,22 19:4,10,14
20:20 23:18 27:16,16 28:4,6 29:
13 31:7 32:5 33:18,22 34:7 35:9
37:14 39:11 40:20 44:2,2,3,4 52:9,
16 55:11,17 57:14 61:3,5 63:20
69:5 82:4,6 84:21 133:2 144:2,8,
10 145:1 147:2 149:13 158:19
160:7 163:15 165:17 175:15 183:
15,16,20 188:1 237:13 242:18
272:1 282:11 287:1 293:13,17297:21
virus-specific [1] 282:17
virusB-you [1] 124:18
viruses [2] 46:13 231:7
visible [2] 17:10 160:20
vitro [2] 176:10 184:9
voice [3] 107:7 119:14 124:5
voices [1] 107:8
VOLUME [2] 1:6 86:11
vote [1] 226:17
Voting [1] 2:13
VX950 [2] 94:16 103:3
Wwait [5] 64:11 205:8 232:20 249:22
270:12
waiting [17] 79:4 153:12,16 154:
13 214:12 215:8 216:21 217:12
219:20 221:11 222:19 223:8 228:
13,14,17 231:22 276:4
Waiver [1] 7:22
waivers [2] 7:17 8:4
walking [1] 213:12
wall [1] 109:21wanes [1] 286:20
wanted [10] 66:12 115:1 126:2
141:2 158:2 190:22 193:21 218:6
284:14 312:6
wants [2] 172:2 243:15warrants [1] 200:11
wasB-and [1] 137:4
Washburn [5] 2:12 5:6,6 9:21 10:
6
Washington [2] 4:21,22
washout [1] 158:21
wasn=t [7] 131:19 157:11,20 160:
9 253:13 254:12 305:11
waterfront [1] 267:1
way [52] 10:18 29:11 33:16 52:4 85:
15 90:8 95:10 13 106:17 109:19
164:8 168:12 179:3 180:5 181:1
192:13 193:18 198:1 202:10 204:
17 205:2 211:19 212:7,10 214:4
220:3 224:13 229:3,9 250:20 251:
3 254:5 255:9 265:3 270:11 271:
20 277:18 287:21 288:14 289:8
291:16,17 298:5 302:18 308:11
311:20
ways [9] 47:7 60:13 61:3 99:1 130:
19 155:1 234:1 271:12 310:4
weak[2]
182:11,15web [2] 8:1,2
website [3] 86:9,12,15
week [7] 32:16 42:9 116:2 163:17
164:6 166:3,7
week=s [1] 164:5
weekly [1] 193:2
weeks [62] 26:7,9 37:19,19 39:11
40:18 41:5 58:20,21 64:4 65:10,
11,19 70:9,11,13 72:1,1 85:10 91:
19 99:21,22 100:7 109:9,10 116:3,
7 118:10,16 119:14,17 120:21
121:4,9,20 122:2 123:11 132:21
133:1 139:15,16 143:2 155:11,11,
13 156:19,19,21 157:19,22 159:12
161:3 166:3,22 168:17,18 192:13252:13,13,22 263:7 264:6
Weight [3] 69:7,21 164:1
weight-based [1] 71:3
welcome [1] 106:9
well-characterized [1] 193:15
weren=t [2] 104:19 254:16
whatever [14] 29:20 31:9 84:21
129:2 146:22 191:20 198:15 205:
15 220:2 221:2 250:1 256:19 269:
8 276:18
wheels [1] 193:11
whereas [1] 119:7
Whereupon [2] 171:11 313:1
wherever[1]
139:5whether [43] 13:7,8,15,21 14:9 32:
11 36:21 40:3 62:15 80:4 124:13
136:2 139:20 143:5 150:3 153:5
160:10 161:10 162:13 168:9 191:
20 197:10 201:20 203:4 205:3
216:1 218:2 224:2 244:6 246:19
247:13 265:9,14 267:15 274:6
279:10 282:16 284:15 296:14 297:
13 299:20 304:12 305:22
whichever [1] 295:15
white [4] 47:3 88:15 89:3 309:10
whites [9] 75:18 201:1,9 304:3,14
306:9,9 307:3 310:19
whoever [1] 207:8
whole [11] 38:2 50:4 59:13 77:4157:9 205:7 227:2,14 231:11 299:
1 309:11
whom [8] 134:18 141:19 222:19
235:22 264:20 279:7 297:19 306:
19
widely [1] 148:6
will [179] 4:17 6:11 9:2,9,10,18 10:1,11 11:5,6 13:2 15:12,14,16,17,
18,20 16:22 17:3,6 19:1 21:2 25:3
28:4,6 37:12 39:22 48:5 49:19 50:
16 64:12 66:9,13 68:9,17 77:7 78:
13 83:10,12,12,16,19 84:4,8 89:7,
9,11 90:1,11,20 93:17,19 99:12
101:3,6 102:5,6 106:3 107:19 108:
4 109:9,10 117:6,7,18 120:3 121:
22 126:7 127:3 133:2 136:3 138:
11 139:21,22 140:1 142:10 149:
17,18 151:14,21 152:18,20 153:4
154:5,6 157:8 158:16 160:18 168:
1,2,5,10 170:20 171:4,6,8,10,20
172:4,7 173:10,14 175:2 176:4177:15,19 178:7 181:13 183:5,15
184:4,11,11 185:10 186:2,4,11
191:9 193:10 197:6,16 204:9 205:
8,10,12,14,16 206:1 208:9,18 210:
15 213:10 217:8 219:11 220:3
226:19 228:15,15 229:6 234:22
237:21,22 238:2 245:3 247:13
249:21 251:4 255:15 256:18,20
257:19 258:1,12 262:18 264:20
269:15 272:4,13 278:15 280:6,10
283:13 285:15 288:1 291:3 296:4
299:14 302:1,2,6 312:4,21
William [2] 2:24 3:24
willing [3] 175:2,12 298:16
window [2] 37:18,21Wisconsin [1] 5:2
wish [4] 9:6 52:1 172:8 208:8
withB-if [1] 230:21
Within [32] 19:11 22:22 27:4 32:16
40:11 45:6 59:6,20 61:5,11 62:20
63:1,13 64:12 65:10 67:1 73:20
74:7 85:10 121:19 162:10 234:11
257:14 262:8,10 271:18 274:18,
19 284:7 292:2 302:12 308:12
without [27] 57:1 81:6 93:6 100:22
126:10 129:16 131:22 148:20 149:
10 160:6 161:1 168:4 182:2,7 208:
21 212:11,13 217:12 240:10 247:
5 265:19,21 279:10 297:4 298:12304:21 306:4
woefully [1] 275:2
women [7] 38:19 45:3 46:11,12
188:14 201:14 308:19
won=t [4] 101:1 207:9 288:19 300:
10
wonder [2] 159:19 160:9
wondering [3] 85:21 211:17 300:
16
word [2] 84:22 307:17
words [18] 30:5 44:19 65:1 114:1
118:10,15 131:12 132:1 149:1
151:15 164:15 165:14 176:22 215:
17 224:5 249:7 252:16 305:4
work [27] 22:16 34:8,12 42:5 73:2292:1,2 132:7 164:20 189:19,21
190:12 194:19 200:1,20 227:19
229:16 245:9 256:15 262:14 269:
18 284:2 290:19 303:13 309:14,
15,17
worked [8] 85:5,7,12 165:1 191:4
242:3 263:8 310:5
worker [1] 26:3
workers [2] 24:8,9
working [7] 49:22 59:12 85:2 125:
works [10] 130:17 200:1 231:5 232:
4 245:10 254:6 297:11,15,18 303:
14
world [15] 17:9 20:15 28:20 29:1
42:18,20 43:2 89:7,11 188:4 202:
7 236:1 245:17 247:19 277:1
worldwide [2] 11:1 21:7
worms [1] 252:2
worried [1] 283:9
worries [1] 301:10
worry[1]
231:12worsening [2] 127:14 150:13
worst [2] 217:18 276:6
worth [6] 159:7 164:5 210:9 230:6
235:13 255:11
worthy [2] 170:5 243:12
wouldn=t [9] 64:19 154:19 157:7
204:13 211:10 212:4 245:9 266:
22 271:7
wrist [1] 240:2
write [1] 138:9
writing [1] 173:14
written [3] 8:5 132:10 172:20
wsd [1] 310:18
Xxenograft [1] 184:9
Yyear [24] 10:18,21 22:14,17 23:15
45:7 48:4,5 54:15,18 74:7 86:14
106:17 136:8 137:6 141:18 146:4
149:18 168:1 215:7 228:14 252:
21 281:10 292:2
year,@ [1] 250:1
year-Bwell [1] 252:21years [68] 10:4 17:18 20:22 25:17
26:20 27:7 39:10 46:1,14 49:1 50:
1 54:3 55:3 57:2 64:9 73:6 74:5
84:13,13,15 85:1,18,21 86:1 87:2,
8,11 89:1 100:15 101:7,9 103:2,9104:1,5,9,15 105:8 136:1,13 137:
11 141:12,14 142:1 148:4 149:9
160:10 168:4,6,11 175:17,22,22
176:2 187:2,2,3 241:11 274:18,19
286:4,13,19 288:1,7 289:5 296:4
297:5
years-Band [1] 39:22
yellow [2] 69:2 71:6
York [6] 5:5,16 86:7 87:10 89:20
98:4
young [3] 45:2 46:12 291:5
younger [1] 292:8
yourself [2] 16:7 165:15
Zzero [5] 29:15,17 30:6 31:19,20
zone [1] 292:12