Replies to post #443188 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

Submission of the MAA is what starts that clock.

Missling needs to move with a sense of urgency for once and get that MAA filed by mid year 2024 at the latest. Hopefully AVXL has already done work on the application since it has obviously been meeting with the EUA reps for a while.

[Doc328]

Never let a fact get in the way of WGT.

The pertinent section is 2.2 (quotes below from p. 35 and p. 36). So 7 months from request to use the centralised procedure which would mean 6 months from the eligibility request being granted is the earliest for MAA submission (clock starts after this is accepted). The eligibility request is valid 3 years and may be renewed so upper limit for MAA submission is open ended.

EMA recommends providing the eligibility request preferably, at the earliest, 18 months before
submission of the marketing authorisation application (MAA) and, at the latest, 7 months before the
MAA is filed with the EMA, at which point it could be submitted as part of the “letter of intent to

The eligibility to the centralised procedure under optional scope is accepted for a period of 3 years
from the time of CHMP adoption. It is the responsibility of the applicant to monitor the lapse of the
acceptance period. If an extension is intended, the applicant should submit a new eligibility request
under optional scope, and review of eligibility application will take place over 2 consequent CHMP
meetings.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en.pdf

smh

[boi568]

I don't agree with your time line. We are pre submittal, true, but the EMA has already affirmatively responded to the Centralised Process request. The ball is in Anavex's court, and they will, per today's PR, submit "as early as possible in 2024" without a concern that the EMA will reject the submission.

What could be the point now of having to wait until June to make the formal submission? It's not like they have to negotiate more with the EMA to receive the go ahead they already have in hand. They have told us today they aren't going to wait until June.

[Investor2014]

Correct, Anavex is stil at the "Pre-submission – Actions" stage.

I don't think Anavex has submitted it MAA yet. Submission of the MAA is what starts that clock.

As per the table and flowchart here: EU Regulatory procedures for a marketing authorisation (MA).

Things becomes more interesting from the "Evaluation Procedure – ACTIONS" stage taking 1 - 120 post submission. The PR today said "Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024".

Let's say the submission is completed by end Q1-24, then end Q2 the clock is restarted with Anavex submitting responses to queries, which could go on for another quater. All being well the 67 day clock for approval or not, could start ticking end Q3 2024. So the best outcome could be approval by the very end of 2024 or more likely just into 2025, obviously along the way with delays possible depending on the quality of the Anavex submission and hiccups to resolve.

But something $AVXL exciting is now at last set in train.