Replies to post #458304 on Anavex Life Sciences Corp (AVXL)

[frrol]

Should add that though it's the FDA relaxing its AD guidelines, there's a chance the EMA shares this view.

[WilliamMunny]

frrol, if the EMA shared the view that contingent approval would be the more appropriate outcome for 2-73 on its current AD data, would they not have steered Missling to apply for Conditional Approval rather than Full Approval?

[Anshu2]

Regarding small vs large trials: Most AD trials (except AVXL's) have indeed been very large -- but that is likely because the expected change in endpoints has been small. AVXL was expecting a larger change -- so, went with a smaller trial to save costs. Ultimately, p-value is what really matters (if safety is not an issue).

In either case, with respect to FDA/US, there may be a tiny change of AA (based on biomarker data) -- but otherwise AVXL needs another trial anyway for FDA approval (this new trial will likely be a large trial -- since the smaller one "failed").