Anavex Life Sciences Corp (AVXL)

[abew4me]

Well, let me try to explain repurposing a drug in simpler terms...

Let's assume that the FDA approves A2-73 for Rett. That means that the FDA has approved a specific dosage for that specific disease.

Now, Anavex has to prove to the FDA that A2-73 is also effective for Fragile X - which is a new disease that is listed in our pipeline. And the only way to prove that it is effective for Fragile X is by conducting a separate P3 trial that is double-blind, placebo-controlled, multi-centered with enough n to satisfy the FDA. (We can skip the P1 and P2 trials because the FDA already knows the drug is safe via the Rett approval)

So, for every new disease that is listed in our pipeline, we will need to conduct a P3 trial to prove its efficacy.

Fortunately, we already conducted a P2b/3 trial for Alzheimer's Disease so Anavex can use that study for the P3 requirement. (When you repurpose an FDA-approved drug and submit a P3 trial, the FDA will consider it for an NDA)

BTW, we only conducted a P2 trial for PDD, so we will need to conduct a P3 trial for that disease.

I hope that makes sense to you.