Replies to post #444228 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

Now we can both be more optimistic about the timing of the MAA!

Like you, I also don't see anything in the Anavex PRs about "letter of intent." I believe this paragraph from the Nov 20 PR is referring to the same thing as the letter of intent:

Pursuant to the discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.

Responding to this last message of yours, I tried to figure out the difference between the "submission of eligibility request" and the "[Notification to the] EMA of the intended submission date (letter of intent)." My conclusion is that Anavex never PRed the eligibility request, and that the December 19 PR is acceptance of the "[Notification to the] EMA of the intended submission date (letter of intent)."* The letter of intent sent by Anavex had to be submitted 7 months before submission of the marketing authorisation application. And that had to be done before the CHMP review could take place. So Anavex unquestionably is within under 7 months of submitting its MAA, almost certainly under 6 months, and very likely considerably closer even than that. If we knew when they'd submitted their letter of intent (which we don't know), we'd know when they will submit the MAA. So forget what I said in my prior message about 18 months. It's definitely less than 7, probably quite a bit less because there had to be time for CHMP's review. I have an optimistic, aggressive view of the Dec 19 PR's statement:

Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024.

I think submission of the Marketing Authorisation Application will probably occur before the end of the first quarter of 2024, or soon thereafter at the latest.


* It has to be the latter because the Committee for Medicinal Products for Human Use (CHMP) isn't involved until then.
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step