Monday, May 29, 2023 3:49:49 PM
I am agreeing with Anshu, and you are correct in your characterization of my 2b/3 reference.
The ab/tau biomarkers pertain to anyone with AD, so an accelerated approval will not care about subgroups. This makes an AA route the more attractive commercial option, in my opinion; it will give Anavex the opportunity to tweak the second trial just a bit to ensure even stronger results while maintaining an NDA claim on a population defined by disease stage rather than disease stage and genomics.
There should be no regulatory requirement for a subsequent AD Precision Medicine trial, then, unless Anavex will be deemed to have failed the 2b/3. Given Missling's repeated, at-risk remarks to the contrary, as well as the indicated presence of the amyloid biomarkers, this seems quite unlikely.
This would not necessarily be the case if Anavex were seeking a final approval without relying on the accepted biomarkers; it may well be true that blarcamesine does not work for all genomic variations. However, I think Missling is planning to navigate around that obstacle by cynically using these fairly useless biomarkers for his effective drug's NDA. To be fair, though, Biogen and Lilly are doing the same thing for their ineffective drugs. He will making that favorable comparison to the FDA.
The ab/tau biomarkers pertain to anyone with AD, so an accelerated approval will not care about subgroups. This makes an AA route the more attractive commercial option, in my opinion; it will give Anavex the opportunity to tweak the second trial just a bit to ensure even stronger results while maintaining an NDA claim on a population defined by disease stage rather than disease stage and genomics.
There should be no regulatory requirement for a subsequent AD Precision Medicine trial, then, unless Anavex will be deemed to have failed the 2b/3. Given Missling's repeated, at-risk remarks to the contrary, as well as the indicated presence of the amyloid biomarkers, this seems quite unlikely.
This would not necessarily be the case if Anavex were seeking a final approval without relying on the accepted biomarkers; it may well be true that blarcamesine does not work for all genomic variations. However, I think Missling is planning to navigate around that obstacle by cynically using these fairly useless biomarkers for his effective drug's NDA. To be fair, though, Biogen and Lilly are doing the same thing for their ineffective drugs. He will making that favorable comparison to the FDA.
Recent AVXL News
- Anavex Life Sciences Highlights New Scientific Findings on Shared Biology Between Autism and Alzheimer’s Disease • GlobeNewswire Inc. • 04/14/2026 11:30:00 AM
- Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/07/2026 11:30:00 AM
- Anavex withdraws EU approval filing for Alzheimer’s therapy • IH Market News • 03/30/2026 12:39:26 PM
- Anavex Life Sciences Provides Comprehensive Regulatory Update • GlobeNewswire Inc. • 03/30/2026 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 08:06:00 PM
- Anavex withdraws EU marketing application for Alzheimer’s therapy blarcamesine • IH Market News • 03/25/2026 02:06:58 PM
- Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/25/2026 11:30:00 AM
- Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease • GlobeNewswire Inc. • 03/23/2026 11:30:00 AM
- New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease • GlobeNewswire Inc. • 03/20/2026 11:30:00 AM
- Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference • GlobeNewswire Inc. • 03/17/2026 11:30:00 AM
- Anavex Life Sciences to Present at the Citizens Life Sciences Conference • GlobeNewswire Inc. • 03/03/2026 12:30:00 PM
- Anavex Life Sciences to Present at the 46th TD Cowen Annual Health Care Conference • GlobeNewswire Inc. • 02/25/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
- Anavex Life Sciences Appoints Seasoned Healthcare Leader to Board of Directors • GlobeNewswire Inc. • 02/23/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/09/2026 09:40:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2026 12:31:17 PM
- Anavex Life Sciences Reports Fiscal 2026 First Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/09/2026 12:30:00 PM
- Anavex Life Sciences to Announce Fiscal 2026 First Quarter Financial Results on Monday, February 9, 2026 • GlobeNewswire Inc. • 02/03/2026 12:30:00 PM
- 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
