Anavex Life Sciences Corp (AVXL)

[Investor2014]

Of course possible but rare that CHMP recommends conditional marketing authorisation (CMA) requiring a post-approval (confirmatory) trial. A CMA needs annual review and extension while the post-approval trial is conducted.

It is a good question how much safety, convenience and efficiency counts towards unmet needs against SOC versus how CHMP views efficacy based on their own analysis assessment of the Anavex data.

I remain 75% sceptical until hopefully we see the EMA clock ticking again.

Meanwhile, I note with interest how posters here now begin to count on subgroup instead of full approval.