Replies to post #465559 on Anavex Life Sciences Corp (AVXL)

[Doc328]

That would be my assumption as well. Initiated in mid November 2023 and told eligible for centralized procedure announced a month later . So we are at 8 months now. I don't know why some people are stating the earliest is November 2024. EMA is slow but not that slow. Its a moot point as any application based on the single 2b/3 will be unlikely.

https://www.anavex.com/post/anavex-initiates-regulatory-submission-of-oral-blarcamesine-for-alzheimer-s-disease-to-european

https://www.globenewswire.com/news-release/2023/12/19/2798446/29248/en/Anavex-Received-Agreement-from-the-Committee-for-Medicinal-Products-for-Human-Use-CHMP-for-the-Submission-of-a-Marketing-Authorisation-Application-of-Oral-Blarcamesine-for-Alzheime.html

[Steady_T]

The Nov PR was an acknowledgement of eligibility for the centralized process. It made no reference to LOI.

The LOI states a date that the company expects to submit its MAA. That date has to be a minimum of 7 months after the LOI date.
I have asked IR about the LOI and got an indefinite answer on if it had been filed or not. I haven't inquired about that in several months.

If you count backwards 7 months from October, the first month in Q4, you arrive at March for an LOI. Whatever that calculation is worth.