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Saturday, February 05, 2022 5:31:22 AM
This bit is causing me bib bib bib, does not compute trouble.
It is inconsistent with the official 8-K files PR as quoted below.
According to above the changes made to the AVATAR trial were NOT approved by the FDA. It does of course not mean that the FDA might disagree if or rather when Anavex plan "to meet with the FDA to discuss the approval pathway". When is that meeting planned for; soon, just around the corner or year-end after the EXCELLENCE readout, that is THE question?
I don't believe the FDA would proactively reach out to Anavex, or any company, with advice to change the primary endpoint and upgrade the trial from P2 to P3. Guidance from the FDA would come during a formal meeting appointment. Just like I am sure Anavex had planned meetings with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and in Australia by the Human Research Ethics Committees (HREC).
The only time FDA will reach out directly is to halt a trial for safety based on a DSMB/DMC trial report.
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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