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go avxl

08/03/23 12:06 AM

#425595 RE: abew4me #425593

get a NDA first

Take slow poke TGD BS forever

Suppose Happen for AD @ Q1

Boopka

08/03/23 8:39 AM

#425602 RE: abew4me #425593

Abe, really excellent post. Thank you.

LBSR TO DA MOON

08/03/23 9:04 AM

#425604 RE: abew4me #425593

So maybe this is exactly what Missling is referring to when he states "you'll know why we did it the way we did it after we do it" or whatever that quote is that he has used multiple times in the past?

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. (Qualifying for the $100M voucher is a bonus)
Our FDA guys know what they're doing...especially Dr. Jin.
I'm just sitting back and enjoying the ride. smile
Cheers.