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Re: frrol post# 474784

Saturday, 11/23/2024 2:46:29 PM

Saturday, November 23, 2024 2:46:29 PM

Post# of 515634
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
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