Anavex Life Sciences Corp (AVXL)

[RedShoulder]

First, a one fifth (or one quarter, or one third) "response rate" in the 50 mg cohort -- "response" in this context being defined as absolute improvers -- in this disease is not too small to justify an approval. DAYBUE was just approved with thirteen percent improvers for Rett. Further, Aduhelm and Leqembi were each approved for AD with zero "responders" as we are defining it here. I am not familiar with cancer drugs, but I imagine this level of disease modification would be hailed as a breakthrough, rather than an intriguing failure.

Second, this level of response would be unprecedented in a properly controlled and blinded AD trial. Keep in mind that Anavex set the bar for improvers high enough to filter out the not inconsiderable placebo noise in a 48 week trial. The company has repeatedly stated the endpoints were met; short of inexplicable fraud (which would be easily caught), the burden of random chance you have assumed is beyond bearing.

Excellent and well thought out points boi; but your first two points nails down why I believe that the Ph-2b/3 trial will be more than sufficient to be awarded FDA approval. Especially in light of Biogen's two FDA approved AD drugs that do not show significant efficacy; whereas Anavex's novel approach does just that, and is much safer than the brain swelling and bleeds experienced with Biogen's AD drugs.