| Followers | 60 |
| Posts | 11421 |
| Boards Moderated | 0 |
| Alias Born | 01/31/2008 |
Friday, April 05, 2019 8:12:03 PM
Great summary Jonjones. You even got the side quotes, as if you were there.
your brother came loaded for bear, asked a lot of good questions.
Only thing I might interpret differently:
Someone asked if there would be another trial after the phase 2B/3. Missling stated that this one is our phase 3 not a pre-phase 3. I’m taking that to assume that no other trial would be needed afterwards.
I took this a bit differently. Dr. M said a 2B/3 is a p2 trial structured to the parameters of a p3 trial. So yes in terms of quality it is exactly what they would run as a p3, including large sample of 450. As whether govt thinks that way, Missling would like them to take it as such, and got directly to P4 with accelerated approval, but he was very conservative in setting expectations by saying FDA could require p3 because so many people would take this drug, huge market.
NO discussion of 371 for those who asked.
your brother came loaded for bear, asked a lot of good questions.
Only thing I might interpret differently:
Someone asked if there would be another trial after the phase 2B/3. Missling stated that this one is our phase 3 not a pre-phase 3. I’m taking that to assume that no other trial would be needed afterwards.
I took this a bit differently. Dr. M said a 2B/3 is a p2 trial structured to the parameters of a p3 trial. So yes in terms of quality it is exactly what they would run as a p3, including large sample of 450. As whether govt thinks that way, Missling would like them to take it as such, and got directly to P4 with accelerated approval, but he was very conservative in setting expectations by saying FDA could require p3 because so many people would take this drug, huge market.
NO discussion of 371 for those who asked.
You have to ask yourself, "Do I feel lucky?" Well, do you short punk?
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
