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Saturday, March 30, 2019 3:09:18 PM
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.
Recent AVXL News
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 13, 2024 in Anavex Life Sciences Lawsuit - AVXL • PR Newswire (US) • 04/16/2024 09:45:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/12/2024 09:45:00 AM
- Anavex Life Sciences to Present at the Noble Capital Markets Virtual Healthcare Equity Conference • GlobeNewswire Inc. • 04/11/2024 11:30:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/09/2024 09:45:00 AM
- Anavex Life Sciences Corporation Class Action: The Gross Law Firm Reminds Anavex Life Sciences Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of May 13, 2024 - AVXL • PR Newswire (US) • 04/05/2024 09:45:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
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