Replies to post #450995 on Anavex Life Sciences Corp (AVXL)

[boi568]

Your sequence of events appears consistent with mine, which begs the question, How did the 2018 changes affect the 2011 NIH description of the process?

[Joseph_K]

The LOI must have been filed with EMA, as we appear to agree several months ago, who then recommended filing a MAA for the centralised procedure.

Actually, we don't agree on that. I can't tell if the LOI has been filed. I believe the recommendation to file a MAA for the centralised procedure is one of the standard two EMA responses to a company's Submission of Eligibility Request. Theyp EMA either makes that recommendation or it tells the company not to proceed with the centralized procedure. I can't tell whether Anavex has filed a LOI. I see two items of evidence that they have, both from the December 19 PR: (1) that it was the CHMP that granted them eligibility and (2) that Anavex aims "to submit the Marketing Authorisation Application as early as possible in 2024."

As to (2), I've recently pointed out its unfortunate ambiguity. As to (1), I, like you, don't see CHMP involved before the MAA is filed (but I'm judging only from the two webpages I've relied upon for the EMA centralized procedure). It's plausible to me that CHMP is involved in evaluating the Submission of Eligibility and that those webpages don't reflect it*, but you say it isn't. If CHMP was not involved, "clerical error" is a gross understatement; it's not like a secretary accidentally added it. I'm displeased by the lack of clarity in the PR.


* The EMA possibly omitting when CHMP first gets involved is very different from it failing to list a submission required of the applicant. The overall purpose of the EMA webpage is to provide the applicant with a summary guide of what it needs to do. Whether or not it's the CHMP or some other body that reviews the SOE is not critical information.

[Steady_T]

The CHMP plays a vital role in the authorisation of medicines in the European Union (EU).

Centralised procedure
In the centralised procedure, the CHMP is responsible for:

conducting the initial assessment of EU-wide marketing authorisation applications;
assessing modifications or extensions ('variations') to an existing marketing authorisation;
considering the recommendations of the Agency's Pharmacovigilance Risk Assessment Committee on the safety of medicines on the market and when necessary, recommending to the European Commission changes to a medicine's marketing authorisation, or its suspension or withdrawal from the market.