Replies to post #453620 on Anavex Life Sciences Corp (AVXL)

[boi568]

I think the EMA will not be making announcements short of a final approval/ disapproval decision. Why should they?

And I don't see anything like Investor's supposed critical EMA submission acceptance step. Anyone who has submitted forms to a regulatory agency (or a court, for that matter) understands that required forms are accepted after a brief review for completeness and fee paid. This is not a substantive moment in the administrative process.

In this case, for example, the EMA is not going through a professional evaluation of the merits of an, e.g., 100,000+ page package on the day it is brought before them. That's what the subsequent 12 months or more review time is for. In some format the MAA will be time stamped as received and accepted -- starting the clock -- and then the Agency's real work will begin.

[Investor2014]

My understanding is that companies sensibly wait to announce an MAA filing after the brief Day-1 validation.

[WilliamMunny]

Joseph, as to your question regarding submission announcements by the company and/or the EMA, I can recall on at least one occasion Missling saying that the company would announce the filing of a formal drug application. (I don't know if he meant after acceptance or prior or both.) As to the EMA, my correspondence earlier in the year with a Greek woman in the Regulatory Affairs department yielded the following response: "There is usually an announcement at the start of the marketing authorization assessment when the dossiers are received which you will find out by following the announcements that EMA is doing periodically." Vague enough for bureaucratic purposes?