Sunday, August 29, 2021 3:26:24 PM
You have responded on two points. The first relates to the process of achieving regulatory proof for a drug's safety and efficacy. The first post in this chain was blarcamesine-specific, but since the issue it raised was a more general question my response was not blarcamesine-specific. That's because Anavex doesn't get special treatment from regulators. So you have misread my comment in that respect.
I agree that 2-73 is safe. There was just a safety peek that confirmed this. However, the general point I made remains intact, that there is a higher price attached to cutting short the drug approval process than might be gained in the short term by more quickly marketing drugs that ultimately will be found approvable.
You have made two errors here: first, misconstruing the context of my remark and second, making the as yet unproven assumption that 2-73 meets FDA efficacy standards.
As to your Australian argument, you are incorrectly characterizing the 225 participants there as constituting a separate trial arm. Not so -- there are three trial arms based on dosages and placebo, not on geography. The Australians may be in their own time zone, but they are not in their own trial arm. And what if they were? How do you justify stopping one trial arm ahead of the others when in a placeboed trial they must remain linked?
I agree that 2-73 is safe. There was just a safety peek that confirmed this. However, the general point I made remains intact, that there is a higher price attached to cutting short the drug approval process than might be gained in the short term by more quickly marketing drugs that ultimately will be found approvable.
You have made two errors here: first, misconstruing the context of my remark and second, making the as yet unproven assumption that 2-73 meets FDA efficacy standards.
As to your Australian argument, you are incorrectly characterizing the 225 participants there as constituting a separate trial arm. Not so -- there are three trial arms based on dosages and placebo, not on geography. The Australians may be in their own time zone, but they are not in their own trial arm. And what if they were? How do you justify stopping one trial arm ahead of the others when in a placeboed trial they must remain linked?
Recent AVXL News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2026 12:15:26 PM
- Anavex Life Sciences Receives Expected Nasdaq Delinquency Notification • GlobeNewswire Inc. • 05/22/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2026 08:15:25 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/14/2026 08:15:30 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/11/2026 08:30:22 PM
- CEO Transition and Delayed SEC Filing Put Anavex (AVXL) Leadership Changes in Focus • IH Market News • 05/06/2026 02:52:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2026 11:04:59 AM
- Anavex Life Sciences Board of Directors Appoints Former Senior Vice President of Clinical Development Terrie Kellmeyer, PhD, as Interim Chief Executive Officer • GlobeNewswire Inc. • 05/06/2026 11:00:00 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/01/2026 11:18:47 PM
- 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
