Replies to post #444977 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

The PR was pretty clear that the EMU had approved Anavex filing for a centralized marketing process. That means the approval will apply to all EU countries. The other path is National Authorization procedures where each member state has to authorize the medicines for use in their own country.

That is the first step in the long chain of events leading up to an MAA filing.
The next step is sending a letter of intent to file an MAA. That letter will specify a date on which Anavex intends to file its MAA. That date has to be 7 months before the intended submission date. During that 7 month period the EMA selects the Rapporteurs who will evaluate the MAA.

https://learning.eupati.eu/mod/book/tool/print/index.php?id=893&chapterid=822

Obtaining the approval for the Centralized marketing procedure is significant step for Anavex.

However, before a medicine is made available to patients in a particular EU country, decisions about pricing and reimbursement take place at national and regional level in the context of the national health system of the country.

[Investor2014]

What exactly have Anavex been doing since 1st Dec 2022 with the P2b/3 data if not "aggressively" pursuing commercialisation for example by engaging with the EMA many months ago? Lines 1 & 2 in the below table.

Although I am not known here as part of the WGT crowd, I believe the LOI was filed a good while ago and the PR with the CHMP go-ahead on filing through the centralised procedure was the culmination of most of the Pre-Submission actions. That is after completing line 3 in the table below.

My expectation is that Anavex are now doing the final "Pre-submission meetings (recommended)" and/or "Re-confirmation of submission date - before submission", in which case we may be a couple of months from the MAA filing.

EU Regulatory procedures for a marketing authorisation (MA)