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Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in

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Page 1: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 2: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 3: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 4: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 5: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 6: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 7: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 8: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 9: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 10: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 11: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in
Page 12: Food and Drug Administration€¦ · that could be performed on the data from Study REC-C-OOI which could provide a possible path forward to resolve the deficiencies identified in