| Followers | 71 |
| Posts | 9140 |
| Boards Moderated | 0 |
| Alias Born | 03/06/2016 |
Wednesday, December 13, 2017 11:00:12 AM
Missling stated the Rett trial could start this year. For him to say that the IND had to be filed by November 30th, By looking at the charts, I suspect the IND was filed on Oct 19th and between then and now there has been a dialogue (most likely negative) due to the fact the trials did not start by November 19th. We had a 4 day spike in price from Oct 18 - Oct 24 (Wed thru Monday).when IND was submitted Most likely, the FDA responded in about a week seeking additional data and thus the $1 drop the next 3 days. Historically it's logical.
I gather Missling filed for both Rett and PD around Oct 19th and the next week the FDA axed the PD trial and thus the surprise move of PD to EU. It is a surprise moving to EU. No way was that planned when Missling said 3 trials to starting 2017. If PD was to go the EU route from day 1, the EU submission would have been done already. Now we learn in won't be until Q1 2018. Surely someone at HQ missed diagnosis the FDA allowing both Rett and PD to start concurrently.
Bottomline, Missling was able to file 2 of 3 trials and they could have both started this year. However, the FDA saw it differently and may only allow the Rett to start soon. Not both. Thus the surprise move to EU.
IMO, Missling was bold to predict 3 trials starting this year, most likely on input from Fadiran. In the end, imo, both Missling and Fadiran underestimated the FDA's actions.
It hindsight, the above scenario clearly points to what has transpired. Its perfectly clear in my mind. Lets hope the FDA allows us to move forward with the Rett trial soon, by soon I mean January 31st. If not by then, we won't see anything in 2018.
I gather Missling filed for both Rett and PD around Oct 19th and the next week the FDA axed the PD trial and thus the surprise move of PD to EU. It is a surprise moving to EU. No way was that planned when Missling said 3 trials to starting 2017. If PD was to go the EU route from day 1, the EU submission would have been done already. Now we learn in won't be until Q1 2018. Surely someone at HQ missed diagnosis the FDA allowing both Rett and PD to start concurrently.
Bottomline, Missling was able to file 2 of 3 trials and they could have both started this year. However, the FDA saw it differently and may only allow the Rett to start soon. Not both. Thus the surprise move to EU.
IMO, Missling was bold to predict 3 trials starting this year, most likely on input from Fadiran. In the end, imo, both Missling and Fadiran underestimated the FDA's actions.
It hindsight, the above scenario clearly points to what has transpired. Its perfectly clear in my mind. Lets hope the FDA allows us to move forward with the Rett trial soon, by soon I mean January 31st. If not by then, we won't see anything in 2018.
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
