Anavex Life Sciences Corp (AVXL)

[frrol]

Yes. The AA pathway with reliance on biomarkers has really been applied mostly to oncological (eg, anti-tumor) drugs, and not that successfully as you also point out. I thought the FDA decision on Adu would be to do a high-dose, early-disease controlled one-year trial, with at most some conditional approval. Their AA with a 9 year follow on trial window was a surprise for a lot of people, and bound to be controversial.

There is now going to be a lot of public and political scrutiny on the FDA's future AD therapy approvals, and Woodcock put her agency in an even tighter spot. The me-too amyloid/tau therapies will be expected to get the same approval path treatment, and if they don't, their sponsors will raise a stink. And the other experimental therapy sponsors now have to worry if they're facing a reliable or a gun-shy regulatory approval regime.

In the end, good results speak louder than nonsense, and the FDA/US isn't the only game in town for first approval, at least not for us.