Sab - I am with you on all the confusion about the process and still am at this point. But AVXL is not dead the are going to continue to fight for approval, after what choice do they have... My understanding is the data AVXL provided for the original file to the EMA is not good enough for approval. Since last Dec of 2024 AVXL has continued to narrow and establish better result from the OLE and that information has been released per PRs (over this year) by Anavex. But this data is not available to the CHMP per rule. Since the CHMP cannot use this data and have not seen this data they will reject Blarcamesine in Dec 2025 per their formal opinion. The following actions per Anavex documented in the PR release on 14 Nov will occur.
1. AVXL will request a Re-Exam of CHMP opinion.
2. AVXL provide relevant Bio Marker data based on feedback (with the CHMP)
3. The CHMP rules allow an application to Request Re-exam of the decision which would be under taken by a different set of CHMP REVIEWERS that were conducted by the first opinion.
So I guess this is the process and AVXL, I assume, will continue to hammer home at the upcoming conferences the newer data that they pulled out from their analysis over the past year and they will try to get EMA approval about the March 2026 time=frame.
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