Saturday, December 14, 2024 12:10:57 PM
This is not how policy is applied. As far as we can tell, the EMA as a matter of policy does not require the ADL co-primary endpoint for early AD, and the FDA is well on the road to the same place. (Anavex 2024 CTAD slide note; FDA draft guidance.)
Policies need to be reasonable, but they are necessarily somewhat blunt instruments. There is always an occasional instance where you can pretty easily argue against a policy on the merits. For the sake of argument, perhaps this is one of those times -- perhaps. It wouldn't be the case that the EMA, say, would now need to make a policy exception to allow for an approval because of the stats; it's the reverse, the EMA would need to make a policy exception to justify a disapproval.
When you argue that a trial has failed for regulatory purposes for missing an unnecessary co-primary endpoint (even though it fully met the required regulatory primary endpoint), you have lost the plot. It's comparable to the circumstance where a heavy underdog in a sport easily beats the spread and loses, achieving a "moral victory." That's something to feel good about, but it was still a loss. Flip it, and here's a circumstance where we you have a win -- an approval -- but there's something to feel bad about. It's still a win.
What matters is what the regulators want to see at the time they make an approval/disapproval call, not what they or the applicant wanted to see a few years before when the trial was designed.
In other words, it will be an uphill battle here to argue that the 2b/3 trial failed under the terms the EMA uses today. You can argue that it failed on its own terms, or that the EMA's terms are wrong. Both interesting arguments -- to a point -- but irrelevant and a waste of time. The EMA knows how to apply its own regulatory standards, and if it has accepted the argument that the 2b/3 had failed because the ADL co-primary endpoint was not hit, the CHMP would never have green lit Anavex submitting an MAA. Full stop.
Recent AVXL News
- Anavex Joins ACCESS-AD, a Major Initiative Funded by the European Commission, Through the Clinical Evaluation of Blarcamesine as Part of a Precision Medicine Approach in Alzheimer’s Disease • GlobeNewswire Inc. • 01/13/2026 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/09/2026 10:26:26 PM
- Edelson Lechtzin LLP Announces an Investigation of Anavex Life Sciences Corp. (NASDAQ: AVXL) and Encourages Investors with Substantial Losses Contact the Firm • PR Newswire (US) • 01/09/2026 01:13:00 AM
- Anavex Life Sciences Appoints Senior Vice President Global Head of Neurology • GlobeNewswire Inc. • 01/08/2026 12:30:00 PM
- Anavex Life Sciences Receives FDA Feedback on Alzheimer’s Disease Program • GlobeNewswire Inc. • 01/06/2026 12:30:00 PM
- Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion • GlobeNewswire Inc. • 12/18/2025 12:30:00 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 12/12/2025 09:05:00 PM
- Anavex Life Sciences to Present Oral Blarcamesine Data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference • GlobeNewswire Inc. • 11/26/2025 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 11/25/2025 09:31:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/25/2025 12:30:48 PM
- Anavex Life Sciences Reports Fiscal 2025 Fourth Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 11/25/2025 12:30:00 PM
- Anavex Life Sciences to Present at the 44TH ANNUAL J.P. MORGAN Healthcare Conference • GlobeNewswire Inc. • 11/19/2025 12:30:00 PM
- Anavex Life Sciences to Announce Fiscal 2025 Fourth Quarter Financial Results on Tuesday, November 25, 2025 • GlobeNewswire Inc. • 11/18/2025 12:30:00 PM
- Anavex shares collapse after CHMP issues negative signal on Alzheimer’s therapy • IH Market News • 11/14/2025 01:45:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/14/2025 12:42:01 PM
- Anavex Life Sciences Provides Regulatory Update on Blarcamesine for Early Alzheimer's Disease • GlobeNewswire Inc. • 11/14/2025 12:30:00 PM
- Anavex Life Sciences Announces Continued Long-Term Benefit from Oral Blarcamesine Compared to Decline Observed in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) Control Group • GlobeNewswire Inc. • 10/29/2025 11:30:00 AM
- Anavex Life Sciences Announces Presentation at the 35th Alzheimer Europe Conference ‘Connecting Science and Communities: The Future of Dementia Care’ • GlobeNewswire Inc. • 10/10/2025 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/04/2025 12:42:50 AM
- Anavex shares climb on upbeat results from schizophrenia trial • IH Market News • 10/02/2025 12:45:17 PM
- Anavex Life Sciences Announces Successful Development of Once-Daily Oral Tablet Formulation for the ANAVEX®3-71 Program • GlobeNewswire Inc. • 10/02/2025 11:35:00 AM
- Anavex Life Sciences Announces Positive Topline Results from Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia • GlobeNewswire Inc. • 10/02/2025 11:30:00 AM
- Anavex Life Sciences Announces Publication of Oral Blarcamesine Describing a New Class of Clinical Precision Medicine from Phase IIb/III Alzheimer’s Disease Trial • GlobeNewswire Inc. • 09/30/2025 12:30:00 PM
- Anavex Life Sciences Announces Oral Blarcamesine Cognitive Resilience Results Approximating Normal Aging in New Precision Medicine Clinical Data from Phase IIb/III Alzheimer’s Disease Trial • GlobeNewswire Inc. • 09/09/2025 11:30:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 27th Annual Global Investment Conference 2025 • GlobeNewswire Inc. • 09/02/2025 11:30:00 AM
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