Monday, August 14, 2017 10:41:53 AM
IMO, there is an important-subtle change in addition to WW regulatory body rethinks. They (Dr. M.) are saying (IMO)..."this is all about the process". Compared to pass fail/event driven/good bad passed trials.
In AVXL case (I pray this is true) we claim A2-73 (others to follow) is capable of restoring CNS cellular function (Homeostasis). Pre clinical trials and our studies indicate the story is true and the efficacy of the process certainly will be shown. We are developing dose models, but the basic process should be effective. The degree to which this thesis can be proven/demonstrated/studied/evolved/improved remains to be seen. IMO, Dr. M. and team are on the point demonstrating and validating the process. He acts like if we just follow the process we will get the results we are looking for. If he is right then variations of CNS restoration thesis will certainly evolve quickly.
So, the new international trial rules will rely less on sample size and statistical analysis and more on adaptive learning using new tools/methods to validate the concepts. Can we imagine a trial with no adverse events? Get ready, smaller, shorter, faster, more granular and more predictable results. Five years from now we will look back at this moment. It's time to move on but I in no way expect all WW regulatory bodies to evolve the same processes. It is all about a collaborative learning process from here on out.
Recent AVXL News
- ZenaTech, Inc. (NASDAQ: ZENA) First US Trial of IQ Nano Drone for Inventory Management • InvestorsHub NewsWire • 10/15/2024 12:21:48 PM
- ZenaTech, Inc. (NASDAQ: ZENA) To Commence Trading Today • InvestorsHub NewsWire • 10/01/2024 11:00:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024 • GlobeNewswire Inc. • 09/03/2024 11:30:00 AM
- 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
Mass Megawatts Commences Solar Energy Sales Efforts • MMMW • Oct 16, 2024 7:45 AM
SANUWAVE Health Announces 1-For-375 Reverse Stock Split • SNWV • Oct 16, 2024 7:40 AM
Future Hospitality Ventures Unveils Bold, New AI-Driven Initiative to Revolutionize the $300 Billion Hospitality Market • NGTF • Oct 16, 2024 7:07 AM
Kona Gold Beverages, Inc. Announces Strategic Progress and Corporate Evolution • KGKG • Oct 15, 2024 9:00 AM
One World Products Secures First Order for Hemp-Based Reusable Containers, Pioneers Renewable Materials for the Automotive Industry • OWPC • Oct 15, 2024 8:35 AM
ZenaTech, Inc. (NASDAQ: ZENA) First US Trial of IQ Nano Drone for Inventory Management • BURU • Oct 15, 2024 8:21 AM