Anavex Life Sciences Corp (AVXL)

[frrol]

What the FDA is doing is certainly controversial. I think (and many agree) the FDA made a big mistake with Biogen. It's becoming a kind of regulatory trap: if you go with the dubious hypothesis that AB/tau removal is predictive, then you have to be consistent. Hence this Gantenerumab BTD. There are other examples, and there will be more. There's an expression: in for a penny, in for a pound. What a mess.

But AD pathology is extremely complex. There will likely not be a silver bullet but some combo therapy that proves most generally effective. The AB/tau clearing compound may ultimately to be part of it, or at least in some cases. Hopefully our compounds are also a part of it. You keep testing. What the FDA did with Biogen will, I believe, have bad consequences in the near term, but does not absolutely impede our approach or others. For us, we're deep into our Phase 2/3. Our success is strictly up to our compound's effectiveness. And I think Missling is right: the FDA is now showing that they are very open to expediting AD therapies.

(Btw keep in mind that our Phase 2A was not only an extremely tiny trial for such a huge indication, it was not randomized or placebo controlled.)