Tuesday, April 17, 2018 7:06:36 PM
Shareholding Meeting - Part 1
Overall great meeting. Missling graciously answered any and all questions that I had. And I had many. There were about 15 people there in total. I met Missling, Stephan Toutain, and Daniel Klamer. They were all very nice and seemed excited about the company and where it is heading. There were several other Anavex related people there including Clint from IR and a lawyer from K & L among others.
I arrived early and was able to get into a 20 minute discussion with Missling and 2 other investors from the Facebook group. Missling did a presentation with the usual slide deck and included a few new ones. After the presentation we were able to ask questions. I asked every question I could think of and they were all answered the best he could without giving away material information. After the meeting, I was able to meet with Christopher and a few other investors. We spoke about a variety of topics for about 20 minutes.
I’m not a science guy, so I will refer to others to clarify science related topics.
Rett
-Safety not an issue. In order to run the trial with these children, they had to do a Juvenile Toxicity Study required by the FDA. So NO issues there.
-Toutain said the trial would consist of 75 patients. During Missling’s presentation, he said it would be less than 100. So it sounds right.
-The specific patients in the trial are not selected yet. However, they have identified the patient pool from which the participants would be selected. Once the FDA gives the go ahead, screening will be done using the data collected.
-Delay is due to back and forth negotiations with the FDA. The 30 day clock seems more like a rolling clock, not set in stone. Because this is a new drug, using a unique trial design (especially for this indication), they want to do the most to get it done right. And also to get it done so it can be approved out of phase 2.
**All endpoints for all trials will be endpoints that were used in prior trials**. Meaning they are not creating new and improved endpoints.
-RWE will be used to determine effectiveness but will not be a primary endpoint. More likely a secondary peripheral measure and evidence of efficacy.
-There is a very low bar for Rett approval. Minor improvements will result in approval.
-Age range of children not determined yet.
Part 2 and 3 coming
Overall great meeting. Missling graciously answered any and all questions that I had. And I had many. There were about 15 people there in total. I met Missling, Stephan Toutain, and Daniel Klamer. They were all very nice and seemed excited about the company and where it is heading. There were several other Anavex related people there including Clint from IR and a lawyer from K & L among others.
I arrived early and was able to get into a 20 minute discussion with Missling and 2 other investors from the Facebook group. Missling did a presentation with the usual slide deck and included a few new ones. After the presentation we were able to ask questions. I asked every question I could think of and they were all answered the best he could without giving away material information. After the meeting, I was able to meet with Christopher and a few other investors. We spoke about a variety of topics for about 20 minutes.
I’m not a science guy, so I will refer to others to clarify science related topics.
Rett
-Safety not an issue. In order to run the trial with these children, they had to do a Juvenile Toxicity Study required by the FDA. So NO issues there.
-Toutain said the trial would consist of 75 patients. During Missling’s presentation, he said it would be less than 100. So it sounds right.
-The specific patients in the trial are not selected yet. However, they have identified the patient pool from which the participants would be selected. Once the FDA gives the go ahead, screening will be done using the data collected.
-Delay is due to back and forth negotiations with the FDA. The 30 day clock seems more like a rolling clock, not set in stone. Because this is a new drug, using a unique trial design (especially for this indication), they want to do the most to get it done right. And also to get it done so it can be approved out of phase 2.
**All endpoints for all trials will be endpoints that were used in prior trials**. Meaning they are not creating new and improved endpoints.
-RWE will be used to determine effectiveness but will not be a primary endpoint. More likely a secondary peripheral measure and evidence of efficacy.
-There is a very low bar for Rett approval. Minor improvements will result in approval.
-Age range of children not determined yet.
Part 2 and 3 coming
Recent AVXL News
- 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
- Anavex Life Sciences Reports Fiscal 2026 First Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/09/2026 12:30:00 PM
- Anavex Life Sciences to Announce Fiscal 2026 First Quarter Financial Results on Monday, February 9, 2026 • GlobeNewswire Inc. • 02/03/2026 12:30:00 PM
- 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
