Anavex Life Sciences Corp (AVXL)

[boi568]

I am agreeing with Anshu, and you are correct in your characterization of my 2b/3 reference.

The ab/tau biomarkers pertain to anyone with AD, so an accelerated approval will not care about subgroups. This makes an AA route the more attractive commercial option, in my opinion; it will give Anavex the opportunity to tweak the second trial just a bit to ensure even stronger results while maintaining an NDA claim on a population defined by disease stage rather than disease stage and genomics.

There should be no regulatory requirement for a subsequent AD Precision Medicine trial, then, unless Anavex will be deemed to have failed the 2b/3. Given Missling's repeated, at-risk remarks to the contrary, as well as the indicated presence of the amyloid biomarkers, this seems quite unlikely.

This would not necessarily be the case if Anavex were seeking a final approval without relying on the accepted biomarkers; it may well be true that blarcamesine does not work for all genomic variations. However, I think Missling is planning to navigate around that obstacle by cynically using these fairly useless biomarkers for his effective drug's NDA. To be fair, though, Biogen and Lilly are doing the same thing for their ineffective drugs. He will making that favorable comparison to the FDA.