Anavex Life Sciences Corp (AVXL)

[Anshu2]

You misunderstand. For avxl, the process is.

1. What is the surrogate marker? Let’s say it’s X (from CM’s comment it seems like it may be amyloid-beta).

2. P2b/P3 MUST show that the drug had a positive impact on X (wrt placebo) with p < 0.05. Perhaps, higher impact for higher dose.

3. X must be a valid surrogate marker (Ie, it should be reasonably likely to predict clinical benefit).
(a) If X is amyloid-beta, then it has already been accepted as a surrogate marker by FDA —- and there is nothing to do here.
(b) If X is something else, then it’s very tricky — AVXl will have to make a case that X is reasonably likely to predict clinical benefit.

Summary:

1. X better be Amyloid-Beta/Tau.
2. P2b/P3 must show impact on X
3. Rest of the endpoints (Cog, ADL, CBR, etc — ORs or not) only play a supportive role. But if there are very negative results for these endpoints, then a flag would be raised and a valid explanation would be required. But minor issues such as p not being less than 0.05 may not derail acceptance.