Replies to post #474784 on Anavex Life Sciences Corp (AVXL)

[12x]

Since Blarcamesine is absent from the most recent (November) EMA monthly list of drug applications under consideration, it is reasonable to conclude that the MAA has not yet been filed as of November 6. Notably, companies often align their submissions with EMA deadlines, as evidenced by the correlation between previously announced submission dates and these deadlines. With November 25 being the final MAA submission deadline for 2024, it is logical to assume this is the target date for submission. Historically, MAA submissions are typically accepted within three weeks. Therefore, timely submission is critical. This timing also appears to correlate with the delay in the company's Q4 CC.

https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation#monthly-lists-2024-64952

[boi568]

I wouldn't say "acceptance" of the MAA has taken longer than expected (since it has not been announced as submitted), but that preparation, like for the great majority of companies in this position, has taken longer than expected.

It may be that the seven month EMA timeline underestimates what is now being expected of applicants to accomplish by the time of submittal.

[powerwalker]

Is there a reason, frroll, you are lying about the timing of the 10-K filing [You do know Anavex has a September 30th fiscal year-end].

The MAA submission is not a FY 2024 event and will not delay the 10K, which has been extended in the last few years.

Year Date 10-K Filed
2023 11/27/23
2022 11/28/22
2021 11/24/21