Replies to post #383385 on Anavex Life Sciences Corp (AVXL)

[WolfofMia]

Probably waiting for the top echelon of failed biotech investors to stop pretending they know something everyone else doesn't.

Missling: Why haven’t you filed a NDA?

[FooBarAndGrill]

Why? Maybe because NDAs contain a blank section called P3 results?

[Gator328]

I believe Dr. Missling intends to submit the pediatric Rett data first to secure the priority review voucher. Would submitting to the FDA for approval for another indication preclude applying for the voucher if Blarcamesine has already been approved? I don't know. Maybe someone else here does. But that would be one of my several guesses that answers your question.

Another reason is maybe they're still in discussions with the FDA to figure out the best path forward and whether another trial is necessary. Maybe they're waiting for approval in Australia first and will use that to help boost the odds of FDA approval.

It's a good question to ask but I don't think it's appropriate right now to assume that no NDA = bad news or poor management.

[mrplmer]

My answer is that he is lining up the ducks. I think he's going for an NDA for Sigmar Receptor Platform vs individual Drug IND.

[Bourbon_on_my_cornflakes]

You need P3 results first Missling: Why haven’t you filed a NDA?

You need P3 results first. For alz, should be done soon. For Rett, you need Excellence results.

The answer is pretty straightforward if you think a bit.