Anavex Life Sciences Corp (AVXL)

[Veliger]

Biogen burned the FDA once. Don’t count these Lecanemab chickens quite yet.

I’m tired of this phase 3 debate. It’s comical. If our data shows anything near stable disease for half the treated population at one year its done…approved. I guess you’re also just ignoring the massive safety delta and the fact 2-73 is in patients age 5 to 75 across 3 indications and on par w/ placebo vs the brain swelling/bleed numbers ranging from 20-40% across our large molecule competitors. Everyone here keeps comparing trial sizes with Lecanemab and Aduhelm, while failing to recognize both those products FAILED primary endpoints in their initial 2B/3 studies. They had to overwhelmingly prove stat sig with very large numbers because of previous FAILURE, manipulating trial design for the statistics to pan out.

I’m done responding to any more posts on the “oh no, it might need another phase 3”. Wrong. If the data is strong and safety aligned with 5 other trials for 2-73 across 3 indications this is going to happen. A phase 4 is the worst case scenario. The end.

https://alzres.biomedcentral.com/articles/10.1186/s13195-021-00813-8