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Tuesday, December 06, 2022 11:03:42 AM
BTW, during the SRPT's approval saga in 2016, I thought there was a strong flaw in FDA's analysis in the briefing docs, and was compelled to directly write to someone very high up at FDA (think Dunn's head and above, but not revealing the name). That person wrote back immediately (like in 15-20 mins), and said something like "I agree. Send me more points if you wish"). And, to this day, I believe that perhaps my email made a difference (but who knows), since that person was very instrumental in the final approval of the drug.
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Dear Clint,
I want to convey the perception of investors and analysts regarding Anavex.
Over and over again — in particular, in case of AVATAR trial and now the P2b/3 AD trial — Anavex has manufactured new endpoints and evaluated the trails based on these. More importantly, they have ignored evaluation of the original endpoints. Anavex may disagree, but thats the (seemingly valid) perception of the investors and scientists. Most unfortunately, the perception is that same mistake may/will continue to happen for future trials.
Specific examples.
1. In case of Avatar, the company came up with RSBQ-AUC endpoint at the last moment. And, unfortunately, never released the original change-in-RSBQ endpoint.
2. In case of P2b/3 AD trial, the company came up with threshold-based endpoints based on never-before-revealed thresholds. Again, most unfortunately, the company has not released the original change-in-ADCS-ADL endpoint.
RECTIFICATION (if Anavex cares): Release results of the original endpoints and/or answer any questions regarding data inaccuracies. In particular,
1. Release mean-change in RSBQ (not AUC) values in AVATAR.
2. Release mean-change in ADCS-ADL values in P2b AD trial.
3. Clarify a few doubts about the data values in P2b AD trial. (I can send you a short list, if you wish).
I hope you pass on the above feedback to the management. That is the best we (scientists and/or investors) can do.
Thanks for your time and consideration. Your previous reply and promptness was most appreciated.
<Name and Signature/Title>
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
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- 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
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- 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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