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Re: ExtremelyBullishZig post# 439337

Monday, 11/20/2023 9:14:22 AM

Monday, November 20, 2023 9:14:22 AM

Post# of 469494
They met with the EMA and submitted a procedural application that, when likely approved, will save time and money in the future if the MAA is eventually submitted. Good news but is not going to move the SP much.

There are 2 ways a company may choose from to gain approval through the EMA: Centralised procedure and National Authorization procedure --- Anavex has now made a choice, probably the one most companies make. This decision must be made before an MAA is submitted but does not mean the MAA will actually end up getting submitted soon (without additional studies) or even if the MAA is submitted at all.

https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-european-medicines-agency_en.pdf

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en.pdf
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