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Re: Steady_T post# 429237

Sunday, 09/03/2023 10:15:51 PM

Sunday, September 03, 2023 10:15:51 PM

Post# of 462058
The other option is to wait until Rett is approved and repurpose the drug for AD.

Submitting the P2b/3 trial results with a FDA-approved drug should be sufficient to substitute the need for a second P3/4 trial.

Remember, the FDA can approve an NDA (New Drug Application) with one successful P3 trial and the repurposing of an FDA-approved drug.

So, if the FDA approves A2-73 for Rett, that would qualify for the first half of our Alzheimer's application. The other half would be our P2b/3 AD trial.

IMO, this is the main reason why Anavex wants the FDA to approve Rett first. Once it is approved, they can expedite the entire process for our Alzheimer's application by simply repurposing A2-73. (Qualifying for the $100M voucher is a bonus)

I'm not worried at all because our FDA guys know what they're doing...especially Dr. Jin.
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