Anavex Life Sciences Corp (AVXL)

[Investor2014]

You frame it well and it makes a lot sense.

It also means that Anavex will need to put forward a factual and clear defence for the data gaps, size and length of the trial and the in-trial subgroup hypothesis.

I strongly suspect it will also be questioned why Anavex decided not to run a confirmatory RCT in parallel with exploring regulatory pathways (EMA MAA).

I’m still expecting, or perhaps rather hoping for, a conditional approval with a RCT to confirm this new class of treatment is the real deal!

Making it CMA is also a less categoric step for EMA avoiding any later potential controversy.