Anavex Life Sciences Corp (AVXL)

[Anshu2]

Regarding AD P2b/P3's endpoints.

I think its fair to assume that THE endpoints measures (in SAP) were EITHER ORs or LSMs (for ADL and Cog).

1) If they were ORs, then clearly the endpoints were met with statistical significance. Barring some unexplained inaccuracies (but I'm willing to trust AVXL on that -- since CM doubled down on it, that there were no errors).

2) If they were LSMs, then to me September PR is reasonably convincing (p < 0.025 for ONE of the endpoints seems very reasonable statistically; I doubt FDA would mind that -- though I haven't seen a precedence).

With the above in mind -- I think maybe AD P2b/P3 wasn't much of a failure. EXCEPT -- there is this issue about the results for each dosage, which AVXL is still hiding... not sure why. I doubt any regulatory agency would approve a drug based on "pooled" data ...

Anyway, contrary to my earlier pessimism, I wouldn't be shocked if FDA were to ALLOW AVXL to file for an NDA -- but here again the biggest doubt seems to come from the fact that AVXL has been silent about it for 1+ years, so that seems to suggest that FDA has said NO (or AVXL hasn't even approached them).