Anavex Life Sciences Corp (AVXL)

[boi568]

The merits of the trial results aren't affected, of course, by a change to FDA guidance. But that won't matter if a change to the FDA guidance changes the criteria for approval in Anavex's favor. All this is obvious: If the weak spot in the 2b/3 is the ADL outcome and if now the FDA is abandoning the ADL element as meaningless (for the AD stage Anavex was trialing), is there still a weak spot in a potential NDA? Anavex has a good case for biomarkers, especially brain volume maintenance, with an increasingly flexible FDA. Any counterargument would have to focus on the size of the trial, etc., -- but that just leads to an Accelerated Approval scenario with a Phase 4. Every long would sign up for that.

It's not the merit of the trial that ultimately matters, but the chance of the trial to satisfy the FDA that an NDA can be filed. And the same is true in Europe with the EMA, where we have already received a signal that Anavex is in good shape for an MAA.

The drug approval equation has two variables: The trial results and the regulator's subsequent view of the trial results. If just one changes, the whole equation changes.