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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634766.htm?utm_campaign=032919_PR_%20F

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nidan7500 Member Profile
 
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Anavex Life Sciences Issued New U.S. Patent for ANAVEX®2-73 Treatment of Neurodevelopmental Disorders including Rett Syndrom... GlobeNewswire Inc. - 1/8/2020 7:00:10 AM
Anavex Life Sciences Reports Fiscal Year 2019 Financial Results And Provides Clinical Study Updates GlobeNewswire Inc. - 12/16/2019 7:00:10 AM
Anavex Life Sciences to Announce Fiscal 2019 Year End Financial Results on Monday December 16, 2019 GlobeNewswire Inc. - 12/10/2019 7:00:10 AM
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Anavex Life Sciences Presents ANAVEX®2-73 (blarcamesine) Data at 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019 Con... GlobeNewswire Inc. - 12/4/2019 7:00:10 AM
Anavex Life Sciences Receives Rare Pediatric Disease Designation from FDA for ANAVEX®2-73 (blarcamesine) for the Treatment o... GlobeNewswire Inc. - 11/14/2019 7:00:00 AM
Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Rett Syndrome GlobeNewswire Inc. - 11/6/2019 7:00:00 AM
Anavex Life Sciences Announces ATTENTION-AD ANAVEX®2-73 Extension Clinical Study in Early Alzheimer’s Disease GlobeNewswire Inc. - 10/9/2019 7:00:00 AM
Anavex Life Sciences Issued New U.S. Patent for Composition of Matter Covering ANAVEX®2-73 for the Treatment of Alzheimer’... GlobeNewswire Inc. - 10/2/2019 7:00:00 AM
Anavex Life Sciences Presented at the 6th Annual European Rett Syndrome Conference Preliminary Clinical Efficacy Data from th... GlobeNewswire Inc. - 9/27/2019 3:00:00 AM
Anavex Life Sciences to Present at the 2019 Cantor Fitzgerald Global Healthcare Conference GlobeNewswire Inc. - 9/26/2019 7:00:00 AM
Notice of Effectiveness (effect) Edgar (US Regulatory) - 9/23/2019 6:35:19 AM
Anavex Life Sciences to Present at the Ladenburg Thalmann 2019 Healthcare Conference GlobeNewswire Inc. - 9/18/2019 7:00:00 AM
Post-effective Amendment to Registration Statement (pos Am) Edgar (US Regulatory) - 9/17/2019 5:16:10 PM
CLS Holdings (CLSH) $1.15 Price Target - MASS Approval for Recreational License InvestorsHub NewsWire - 9/17/2019 7:17:00 AM
Withdrawal of Registration Statement (ammendment) (aw) Edgar (US Regulatory) - 9/16/2019 4:17:42 PM
Anavex Life Sciences Announces Preliminary Clinical Efficacy Data of its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patie... GlobeNewswire Inc. - 9/16/2019 7:00:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 9/13/2019 5:11:08 PM
Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) Edgar (US Regulatory) - 9/13/2019 5:07:24 PM
Securities Registration Statement (simplified Form) (s-3/a) Edgar (US Regulatory) - 9/13/2019 5:02:44 PM
Anavex Life Sciences to Present at the Janney Healthcare Conference 2019 GlobeNewswire Inc. - 9/5/2019 7:00:00 AM
Anavex Life Sciences Announces Initiation of the EXCELLENCE ANAVEX®2-73-RS-003 Clinical Study in Pediatric Patients with Ret... GlobeNewswire Inc. - 9/4/2019 7:00:00 AM
Quarterly Report (10-q) Edgar (US Regulatory) - 8/7/2019 4:07:28 PM
Anavex Life Sciences Reports Fiscal 2019 Third Quarter Financial Results And Provides Clinical Study Updates GlobeNewswire Inc. - 8/7/2019 7:00:00 AM
Anavex Life Sciences to Announce Fiscal 2019 Third Quarter Financial Results on Wednesday, August 7th, 2019 GlobeNewswire Inc. - 8/2/2019 7:00:00 AM
nidan7500   Saturday, 03/30/19 03:09:18 PM
Re: None
Post # of 231286 
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634766.htm?utm_campaign=032919_PR_%20FDA%20Statement%20on%20Expanded%20Access%20–Looking%20Forward&utm_medium=email&utm_source=Eloqua

This new information from the FDA expresses a new urgency about EA which I have not seen previously. They are more willing to support risk processes based on REAL DATA (WAHT A CONCEPT).I have (in my own mind) linked this emphasis with FDA Precision Medicine initiatives, while mindful of recent Precision Medicine trials in Oncology. I have also linked this with the AVXL emphasis by Dr.M. on Biomarkers in CNS diseases. He did this long before any competition knew what he was talking about. So, the AVXL trials have been focused on Biomarkers leading our trials efforts, so far, so good.

Last week we saw the announced formation of the AVXL (Merck, Sage, other) consortium with a focus on Biomarkers and ERP-AI through a company (Cognision). AVXL has already earlier published an ERP_AI patent for the outpatient use of ERP as a treatment process for AD patients. We also note that Cognision has been granted FDA validation and 510K(K141316) for use as an ERP device in such practices. The patent/partnering w/Cognision presents a non trivial step to Biomarker development in the application of ERP and AI.

The FDA (Dr.G.) knew they were going to nuke the remaining AD Amyloid thesis trials. IMO the corresponding birth of Precision Medicine w/links to Oncology successes. The heavy emphasis by Dr.M. on driving trials based on biomarker Precision medicine initiatives and the fact that our trials are similarly structured tells me that AVXL is way out in front. It also tells me the old shot in the dark methods can still produce a winner but will not be competitive. If this were a rifle range Dr.M. is shooting a very tight pattern.

So what's next? Consistent with the news released on the 29th by the FDA I would anticipate that future p3 approval trials will be more focused on specific Biomarker endpoint. (eg PDD not only movement but corresponding ERP data). Eventually trials will become much shorter, only long enough to verify that the required patient medical end point is met and the corresponding ERP data have been achieved. This kind of process should lead to EA releases under controlled conditions with patients who are in such a position to move on w/their lives as an outpatient. The days of the , " One size fits all" trials are ending. The technology will evolve over time as AD Dementia holding pens get emptied.

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