Saturday, September 27, 2025 1:00:10 PM
When Mayo met with the Anavex reps last month he asked specifically about any interest in applying for the voucher program. The response he received was that they were very interested in this program and they saw no reason why Anavex would not submit an application for the voucher.
It was also mentioned that Missling has recently had a direct phone conversation with Dr. Makary, the new FDA head. No information on what was discussed, could have been about the voucher or maybe just a general “Here is who we are and what we have” type of conversation.
Anavex has also hired a lobbying group to help future legislative paths. Anavex reps as well as the lobbyists have been shown in photos meeting with members of congress. All of this activity strongly suggests that Anavex has atleast submitted an application for consideration in the voucher program, but so have hundreds of other companies.
But for those who keep stating that Anavex isn’t being proactive with regards to FDA, that just isn’t true, we don’t know how much communication has taken place, but there has been atleast some.
It was also mentioned that Missling has recently had a direct phone conversation with Dr. Makary, the new FDA head. No information on what was discussed, could have been about the voucher or maybe just a general “Here is who we are and what we have” type of conversation.
Anavex has also hired a lobbying group to help future legislative paths. Anavex reps as well as the lobbyists have been shown in photos meeting with members of congress. All of this activity strongly suggests that Anavex has atleast submitted an application for consideration in the voucher program, but so have hundreds of other companies.
But for those who keep stating that Anavex isn’t being proactive with regards to FDA, that just isn’t true, we don’t know how much communication has taken place, but there has been atleast some.
Recent AVXL News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2026 12:15:26 PM
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- 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
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- Anavex Life Sciences to Present at the 25th Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/07/2026 11:30:00 AM
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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
- 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
