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Re: Joseph_K post# 445358

Tuesday, 01/02/2024 2:48:06 PM

Tuesday, January 02, 2024 2:48:06 PM

Post# of 463201
That's the future. We are dealing with the current situation. This is only the top line data report. The top line results will come out and may paint a different picture. Whether it will be better or worse is an open question.

It can take up to 60 days to get a meeting scheduled with the FDA for them to provide guidance on how to proceed with these Rett trial results.
Anavex will want to have a full analysis in hand before it goes to the FDA.

What the FDA has to say about the full results will determine how Anavex proceeds. The FDA could recommend filing an NDA, running another trial, or abandoning Rett indication. Based on the small adult trial size I doubt that the FDA will recommend filing for adult Rett only approval.

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