Replies to post #455015 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

Your post assumes that the FDA won't approve an NDA for AD. Why is that?

AVXL announced a totally successful Phase 2b/III trial that met co-primary endpoints. Concurrent with that announcement, AVXL stated that the company would act aggressively to seek regulatory approval. Fifteen months later, all AVXL has is permission to file a MAA in Europe. Importantly, no regulatory path forward, if it exists, has been announced with respect to the FDA. Has AVXL ever even talked to the FDA about the trial results? We don't have a clue about that. All we have is the peer review excuse that doesn't hold water because it is not an FDA requirement for approval. If the Phase 2b/III was a success as claimed, why shouldn't an NDA have been filed many months ago? None of this passes the smell test. So, yes, for the here and now I am taking the posture that no FDA approval for 2-73 for AD is off the table. Could that change eventually? Of course it could.