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Re: rayovac812 post# 429235

Sunday, 09/03/2023 9:55:50 PM

Sunday, September 03, 2023 9:55:50 PM

Post# of 462251
There are several ways that the AD trial might not directly lead to approval. Even if the endpoints in the P2b/3 trial were met the FDA could want to see larger numbers than were in this trial. Also FDA could simply want to see a second P3 trial.

Anavex going for AA would alleviate both of those possible concerns by requiring a P3/4 trial of a size that makes the FDA happy while getting a treatment better than the current AD SOC available for patients.

I can explain it to you, but I can't understand it for you.

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