Anavex Life Sciences Corp (AVXL)

[Investor2014]

A P3 trial was completed when the Accelerated Approval was granted based on the P2 trial. Based on that P3 full approval was then granted not too long after.

Too many confirmatory trials have taken too long to be initiated or even never started. To curb that the FDA has recently firmed up that a confirmatory P3 must be underway when AA is granted.