Replies to post #444571 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

It would certainly [NOT] take 6 months for AVXL to prepare the submission

They have had a year to be working on the submission. They certainly did not start from scratch last week.

Febish is reasonable.

[Joseph_K]

June 2024 for the EMA is the very latest it should be. Anavex's "letter of intent" (aka Notification to EMA of Submission Date) was submitted some (unknown by us) time before Anavex's Dec 19 PR that the EMA had agreed to it. The "letter of intent" is to be sent by the drug sponsor (Anavex) 7 months before the sponsor's estimated date for submitting the MAA.* If the EMA reviewed and approved the letter in one month, and Anavex immediately PRed it, the submission date for the MAA would be June 2024. It seems probable that the EMA took more than a month to agree to the letter of intent, making the estimated date of submission that much earlier.

Missling has not been great on meeting his self-imposed deadlines, but this date -- a (estimated) date promised to the EMA -- is of a different nature. Additionally, as Bourbon said, "They have had a year to be working on the submission. They certainly did not start from scratch last week." I would not be surprised by, say, a March or April submission.


* https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step