Monday, May 29, 2023 5:57:04 AM
So can someone help explain something to me as a layman. With all the trials that we have completed for Alzheimer’s along with the success we have had with our primary and secondary endpoints, we are now looking for approval based on “other endpoints “ or biomarkers . That being the success of reducing the abeta and tau in the brain as well as or better than Biogen and Lilly.
Does that mean that our endpoints don’t matter anymore or just an added benefit that we improve cognitive performance? Do we have to be better than what is now approved with reducing abeta and tau or just close to them because we are just a pill and we don’t require an infusion every 2 weeks? It seems weird to me if this is accurate that we can get approval based on this rather than all the great results we have had on cognition and all the other side benefits of Blarcamisine.
Does that mean that our endpoints don’t matter anymore or just an added benefit that we improve cognitive performance? Do we have to be better than what is now approved with reducing abeta and tau or just close to them because we are just a pill and we don’t require an infusion every 2 weeks? It seems weird to me if this is accurate that we can get approval based on this rather than all the great results we have had on cognition and all the other side benefits of Blarcamisine.
Recent AVXL News
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- 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
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- 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
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- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 11:07:01 AM
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- 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
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- 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
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- 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
