Replies to post #414396 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

I read it as Anavex starting an additional trial that may be a P3 or a P4 depending on how the FDA regards the biomarker evidence. It seems to me that Anavex does not anticipate approval on the basis of the P2b/3 primary and secondary endpoints alone. "Accelerated approval" is for when the endpoint data alone is not adequate and biomarker evidence is needed to bolster it. This was, actually, Investor's argument for the one path to approval without the need for a second P3.

[WolfofMia]

Yes if AA is granted it will be, if not granted it will be a P3.

Either way a trial is needed is my conclusion.

Not a bad thing, is just a thing.