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Saturday, December 01, 2018 10:21:33 AM
This guidance document provides important insights into the context w/in which the AVXL trials are playing out. I am not claiming mine is the only reading to use but it is at least a start for me to make some sense out of what is going on.
We recognize that the AD treatment efficacy," on the path to overt dementia" has check points which trial sponsors have debated.(are the stages even real they say?) The trial debates seem to trip over cognition vs functional diagnostic criteria. We have seen clinical observation text stating they are not sure there really is stage 1, it goes from there. My limited understanding all along has been w/o knowing how to measure AD then we are doomed to multi year trials in an effort to prove some science. So far this trials practice goes no where but it is all there has been.
The brilliance (I claim) of the AVXL trial plan w/PDD and RS is it should show the MOA (thx XENA) demonstrated in these should show/demonstrate FUNCTIONAL (sleep, spasm, movement range, etc) results which are more easily and accurately measured early on a time line. The end points will demonstrate this plan and (IMO) RWE/RWD will support along w/caregiver reports and anecdotes. So what you say, we already knew that. So, before the dementia curtain starts to come down on AD patients valuable time is lost, we have to get that back while we try to develop biomarkers that really tell us something. IMO, that is what is going on right now while we wait for the trials to start. Since AD stage cannot yet be measured w/confidence (functional) until it is too late the PDD/RS trials are vicariously on the point while the AD debate of function vs cognition rages for stage 1,2. The early choice of these two CNS disease trials as indicators (along w/other choices we do not know about) are evidence of a good plan.
Stand by, we are going to actually learn something about CNS diseases, then comes applied knowledge.
Recent AVXL News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
- Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/06/2024 11:30:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024 • GlobeNewswire Inc. • 08/01/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
- Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
- Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at Alzheimer's Association Conference • GlobeNewswire Inc. • 07/28/2024 09:00:00 PM
- 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
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