Replies to post #450940 on Anavex Life Sciences Corp (AVXL)

[boi568]

The sequence is Letter of Intent, followed by the specific request for a centralised procedure. (There is a less ambitious request that could have been made.) The centralised procedure PR came out on October 20, so some date in mid May 2024 likely represents the 7 month mark. It could be sooner.

[Investor2014]

Given that the P2b/3 results were not a clear cut met all endpoints success (despite the erroneous Anavex Dec 1, 2022 claim), I am not surprised that Anavex would chose not to PR the LOI lining up for a potential rejection PR later. Instead Anavex waited for

the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.

The CHMP only takes over after the EMA recommendation for assigned that team for the start of the Day-1 process once the MAA is filed.

The granting of the eligibility from the CHMP under the centralised procedure allows for submission of a single Marketing Application to the European Medicines Agency that, if approved, would allow blarcamesine to be marketed in all EU member states. Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024.

The sentence is blue would only be conceivably correct provided Anavex filed the LOI at least 7 months prior. This would at a stretch allow "as early as possible in 2024" to mean H1. Hopefully we will se the filing in this quarter or perhaps just into Q2. If not there is further trouble ahead.