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Re: bas2020 post# 420456

Wednesday, 06/28/2023 12:39:18 PM

Wednesday, June 28, 2023 12:39:18 PM

Post# of 461949
Anavex has only one shot to get FDA approval for their P2b/3 Alzheimer's NDA...so they need to make sure they include all of the P1s, P2s and P3 trials.

Everyone knows that a successful P3 trial is worth its weight in gold because it's a double-blind, placebo-controlled study...and the FDA values P3 results over all of the other P1s and P2s trials.

And remember, our P2b/3 trial (with only 509 patients) is probably the smallest n that has ever applied for an NDA for AD.

Waiting a few more months to add the Rett P3 trial to our NDA portfolio is just common sense. TGD knows what he's doing.

Cheers.

abe
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