Anavex Life Sciences Corp (AVXL)

[Investor2014]

I think we can assume that the EMA having seen the P2b/3 and at least 48 week OLE data, have at least said ok complete and submit a Marketing Authorisation application.

These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.


Pursuant to the discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.

When that will happen and whether the EMA then accept for evaluation is the next step, just as it would be with the FDA et al.

Can we assume the FDA has not been positive about the chances of an NDA filing? We of course don't know. It does leave the question why Missling staunchly have been claiming that filing would the with FDA first to set the price level for A2-73 if approved, but then Anavex announces EMA first. We don't know if an NDA is being or has been filed and we don't know if the FDA or EMA might approve A2-73 for AD and then which agency would be first.