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Re: crescentmotor post# 420143

Tuesday, 06/27/2023 4:57:40 PM

Tuesday, June 27, 2023 4:57:40 PM

Post# of 461966
When applying for an NDA, it's my understanding that you must submit all of the data that you've accumulated for a specific drug...which would include all P1s, P2s, and P3s from any and all trials.

The more successful trials that you submit with your NDA, the more evidence you have to strengthen your case for FDA approval...especially the P3s because they are double-blinded and placebo-controlled.

Therefore, doesn't it make sense for Anavex to include the P3 data from the Rett EXCELLENCE trial when they submit the NDA for the P2b/3 AD trial?

If you agree with this logic, then that would explain why Anavex hasn't submitted their NDA yet. They're simply waiting for the completion of the Rett Excellence trial.
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