Sunday, February 26, 2023 11:32:35 PM
How long will it take to file an NDA for Rett after the trial is done? Will he be filed by Sept. 30?
Response: “Once we complete this final trial, we will very careful assimilate all the data into a comprehensive filing that clearly shows the overwhelming efficacy of Blarcamesine. Because of Covid, timelines have been so elongated that we don't know how long it will take the FDA to approve the NDA.”
Translation: Rather than get pinned to when AVXL decides to actually file an NDA, let's muddy the situation by alluding to the possible length of time it will take the FDA to approve the NDA.
Why were only one of the 6 stated goals for 2022 achieved?
Response: expect to hear the same answer as in the last call. “The company was very aggressive in it's stated goals and we will be much more focused in 2023.”
Translation: We over-promised and under-delivered but now we're going to be extra careful to use vague reassurances so that we aren't held accountable for our words or lack of actions.
When will we get the 50mg topline data? Why is this taking so long?
Response: “Originally this was designed as a 3 arm study, but because we are able to use precision medicine, we titrated both up and down. This gave us a very robust data set that needs to be very carefully analyzed to determine the exact parameters of our precision medicine approach. The ability to precisely define the super responders from the very good responders from the above average responders will be a crucial component of the data that we will use when we meet with the FDA to discuss the next steps in getting 2-73 approved.”
Translation: We're doing our best to massage the numbers to provide some sort of justification for our claim that we met our endpoints. We have no intention of wasting our money in filing for an NDA because we know that the FDA is going to require a phase 3 trial. We are alluding to next steps so our faithful followers will think we are very close to getting FDA approval for AD when in fact we're at least 2 years away. The “data set will be reviewed” and published is turning out to be a very successful smokescreen.
Recent AVXL News
- 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
- 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
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Avant Technologies Announces Strategic Review Process Intended to Maximize Shareholder Value • AVAI • Sep 4, 2024 8:00 AM