Anavex Life Sciences Corp (AVXL)

[Anshu2]

The BIGGEST consideration (like 90%, certainly when it comes to FDA) in approving a drug is on EFFICACY. Safety, ease of administration, unmet need — etc play only a secondary role.

Anavex AD drug has questionable/unproven efficacy at this point — only one trial and that trial’s endpoints weren’t convincingly (to put it kindly) met. We don’t even know the dose-level data!

It’s that simple.

That doesn’t mean EMA approval chances are zero, BUT they are minimal IMO. FDA approval chances are near-zero, IMO.