Anavex Life Sciences Corp (AVXL)

[Joseph_K]

Agreed, time to step it up on AD submission in the US.

I always thought delaying because of Rett made no sense if AD was so good. (Where's the money? Rett coupon nice, but compared to an Alzheimer's drug?) There was a justification here on iHub I that I always thought was weak, that Rett approval would smooth the way for AD approval. In any event, the EXCELLENCE results killed that excuse.

Anavex can't say they're still waiting for biomarker results.

Even waiting on the OLE is no longer that good an excuse, as it was apparently good enough for the EMA's eligibility agreement; but it's the only reasonable excuse I can think of (provided Anavex is already working on an NDA but (understandably) not saying so), as the FDA has no preliminary step comparable to the EMA's eligibility hurdle to announce, and the EMA MAA submission is still in the future. It would be nice if Missling said the FDA has encouraged Anavex to file, but that's not his style.

Waiting on a peer-reviewed paper would be unbelievable, too: either they know when it's coming out -- which would be before the FDA actually reviews the NDA; or they don't know when it's coming out, in which case Anavex would be letting the AD submission be hostage to the unknowable timing of the peer-review process, which would be ridiculous.