Replies to post #443254 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

The Pre-submission period, as I also said in an earlier post today, could well have started say in March this year and very recently culminating in the CHMP agreement on a MAA submission that Anavex PR'ed today. I still think the table I linked to is fairly clear, also in separating the Pre-Submission, Agreement for Submission and Post Submission process and time tabels.

As I said and is my experience, the submitting company will normally submit fairly soon after being allowed. After all they have just spent about 7 months chewing the cod with EMA advice, while writing away on all the sections of the MAA required for submission, but that may not necessarily fly through without touching the walls of the CHMP and their reviews.

[Steady_T]

Missling said that Anavex had several meetings with the EMA before they Ok'd the start of the MAA process. We don't know over what period of time those meetings took place. So it is a guess that the CHMP acted quickly.

Given the EU bureaucracy I would be surprised if it moves much faster than the regulatory timelines. If they do, that's great. At best Anavex might get the fast track which cuts the 210 day time frame to 150 days. If I am correct that is business days not calendar days.