Anavex Life Sciences Corp (AVXL)

[Anshu2]

If FDA provide AA to AVXL drug for patients with X characteristics (i.e., the label), then the confirmatory trial WILL HAVE to show clinical benefit for patients with X characteristics (i.e., AVXL can't design a confirmatory trial only for patients that satisfy something other than X, e.g., patients with WT SIGMAR1). Else, it wouldn't be a confirmation of the drug's approval basis.

Now, what could X be? It can't be corresponding to a subgroup within P2b/P3 treatment arm --- since FDA is never ever going to approve a drug based on some post-hoc subgroup analysis. So, X will very very likely be at most the inclusion/exclusion criteria of P2b/P3 (which is essentially a broad label).

Point: If AA is granted, the confirmatory trial will have a "similar" inclusion/exclusion criteria as the P2b/P3 trial. Guaranteed.

What name you give to the confirmatory trial -- P2c or P3 or P4 -- is completely irrelevant to anything. It will essentially be a pivotal trial that FDA requires for a full approval, irrespective of the name given.