Thursday, November 26, 2020 12:49:18 PM
The FDA also offers further guidance for formal meetings
Anavex will have a Type B (EOP) meeting. (end of phase)
Tables 1, 2 and A highlight timing issues:
Anavex must request a meeting. FDA has 14 days to respond yes/no
The meeting will be scheduled within 70 days of the request
--- Anavex must get the meeting informational package to the FDA by day 50 and another sentence said within 6 days of meeting request.
The FDA will have complete minutes for the sponsor by 30 days later.
The guidance also goes into detail about information Anavex should have available in the package (submitted shortly after meeting request). Points 14 and 15 are the most relevant for discussion.
From my understanding based on conversations in the past with an SVP Research, the most important thing to pin down with the FDA is the primary endpoint so that the sponsor and FDA are on the same page as to what constitutes a successful phase 3. Realized and potential Adverse events must also be completely discussed for the safety of participants (not a huge issue for Anavex273 compared say to immunosuppressant for MS).
The FDA does not design the study... the sponsor does. But they need to listen carefully to what the FDA says to help design features of the study. The company's statisticians will help decide population size once the primary endpoint is agreed upon. IMO, ADAS-Cog will be the primary endpoint for PDD because of precedence -- it was with Rivastigmine (success on primary and secondary endpoints) and donepezil (failed primary endpoint despite hitting almost all secondary endpoints)
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