Wednesday, January 03, 2024 11:39:13 AM
I disagree with most on this board as to the significance of the recent Anavex PR's regarding applying for the Centralised Procedure (CP) request and then receiving CHMP/EMA eligibility to submit an MAA under the CP. This is a procedural event that streamlines an eventual application submission but does not offer an opinion. The short review would not have looked at much detail of the study.
As an example: To get a concealed carry in my state you need to first take a course from a licensed instructor and pass a simple test and even simpler 30 round target. After this relatively painless 6 hour process they will give you a certificate valid for a certain time (in this example this is analogous to what Anavex has done). Last year, my wife and I both took a concealed carry class and passed. We then took divergent paths. I went ahead to the sheriff's website and completed the application (in this example the MAA) and paid my fee. If I had not done the initial procedural element of the class and passing a test, I would not have been allowed to apply (can't do CP without the initial CHMP/EMA waiver) After the background check I received my CC license. My wife, despite taking the CC class and receiving the certificate (analogous to the CP waiver), opted not to go ahead and do the actual CC application (the MAA). Many other examples like passing the screener on Indeeed.com in order to be allowed to apply for a job but then being told in a screening interview (the rapporteurs) that you are not a good fit before the actual interview (MAA). Obviously the MAA process is more complex. But the point is that receiving permission to apply is not the application. Theoretically, Anavex could apply in June (by my calculations). Anavex has passed a minimum checklist to be given access to the EMA personnel - preclinical trials, GMP documents, human data. Now the EMA will give the emails and phone numbers of the rapporteurs which will open a line of communications. I do not think Anavex will apply in June, or even at all without an additional trial.
Recent AVXL News
- 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
- 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
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