Thursday, December 01, 2022 9:14:15 PM
Well, Mayo was at the event; heard and saw things firsthand. His reports will be wonderful. So glad he could be there.
Just as the presentation started, I enjoyed the fine evening meal my wife prepared. Wasn't able to log back on and see what happened until just a few minutes ago.
But, exactly as I anticipated, blarcamesine, as always in the past, in both murines and real humans, scored another big win; the biggest in its and Anavex's history. The preclinical and early clinical trials all predicted this fine result. Simply, blarcamesine works; always, by all of the ways I and others have described. On out anyone questioning the drug's mechanisms of action (MOAs) is either a fool or is profoundly ignorant.
Like the rest of the posters with scientific competence, I'm eager to scrutinize, understand, and perhaps comment on the clinical details when they become available. Eager to see if the 30mg and 50mg dosing arms can be distinctly separated in the data. Most likely, 50mg will be the preferred dose in further blarcamesine therapies for Alzheimer's.
Most here know this, but I'll lay it out again: In order for the FDA to approve a new drug several criteria must be considered. First, of course, adverse events, side effects, cannot be overly severe. Blarcamesine wins with that; not so common for drugs acting powerfully in the central nervous system.
Next, the candidate new drug's therapeutic outcomes must match or exceed any existing standard of care (SOC) drug for the targeted indication. If the SOC is Aricept, blarcamesine wins altogether. Same for any of the existing or proposed monoclonal antibodies, such as the Biogen drug.
The only remaining question I see is whether or not if the FDA will require another Phase 3 clinical trial, to adequately confirm all that this present study demonstrated. From my perspectives I think there is ample evidence of both safety and efficacy to allow a prompt, outright approval of the drug as a permitted Alzheimer's therapy. But others more familiar with the FDA will more precisely deliberate on that issue.
Next? Clinical trials results for both Rett syndrome and Parkinson's disease dementia. Just as with Alzheimer's, blarcamesine will prove safe and efficacious for both of those indications. After those, it will be trials of Anavex 3-71 for even more CNS debilities.
In the Anavex drug pipelines the valve on blarcamesine feeding into the Alzheimer's container is now open and flowing freely. In 2023, valves in the other pipeline streams will be opened. All along I've predicted that 2023 would be the year Anavex becomes a commercial success. So it will be.
Recent AVXL News
- 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
- Anavex Life Sciences to Present at the Noble Capital Markets Virtual Healthcare Equity Conference • GlobeNewswire Inc. • 04/11/2024 11:30:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/09/2024 09:45:00 AM
- Anavex Life Sciences Corporation Class Action: The Gross Law Firm Reminds Anavex Life Sciences Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of May 13, 2024 - AVXL • PR Newswire (US) • 04/05/2024 09:45:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
- The Gross Law Firm Notifies Anavex Life Sciences Corporation Investors of a Class Action Lawsuit and Upcoming Deadline • PR Newswire (US) • 03/22/2024 09:45:00 AM
- Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia • GlobeNewswire Inc. • 03/18/2024 11:30:00 AM
FEATURED Southern Silver Announces Updated PEA on Cerro Las Minitas: US$501M After-tax NPV5%; 21% IRR; 48 Month payback • Jun 11, 2024 5:26 AM
Swifty Global Announces South African Gambling License Approval • DRCR • Jun 10, 2024 9:15 AM
DaBaby and Stunna 4 Vegas's "NO DRIBBLE" Joins Music Licensing, Inc.'s Portfolio • SONGD • Jun 7, 2024 10:15 AM
Mushrooms Inc. (OTC: MSRM) Announces Significant Share Buy Back by the Board Director and New Strategic Initiatives. • MSRM • Jun 5, 2024 1:32 PM
Hydromer Announces Launch of HydroThrombX Medical Device Coating Technology • HYDI • Jun 5, 2024 10:24 AM
Dr. Michael Dent Finances $1 Million to Drive HealthLynked's Healthcare Transformation • HLYK • Jun 5, 2024 8:00 AM