Friday, May 13, 2022 10:13:43 AM
Good question. Are you aware of any specific A2-73 treatment /applications/tool suite manual now in use WW? Such a manual -treatment guidance will note specific time/intervals for analysis, results records requirements, instruments./controls on maint/calibration. Any lab records of -computer system validations being performed for the specific work being done, compliance of those systems w/FDA regulations.
We could go on but you see the point.
My belief and the basis for my positive reaction to this Patent app is that FINALLY after decades of very sloppy work a disciplined process w/specific industry/regulatory guidance is being put ion the table by serious adults who expect to get results. How the FDA continued for 30 years and billions of dollars w/unlimited smart-hard working staff allowed management to deliver no credible CNS disease solutions,... and they still kept their BIG jobs. All while pts and families hoped and waited...being told ...No effective treatment is available.
I am delighted that Dr.M. and staff have taken on this critical responsibility. It is obvious the established system is flawed.
Now, we have a tiny little Bio firm whose leadership has the stones to step forward w/a specified trial protocol(s) using precision methods . This patent app. will mean a lot and likely also for dedicated MD/staffers who work every day to make a difference. Having a document process w/good controls , strong training and records and a plan on how work will be done/measured/assessed and acted on matters in any process.
The Medical-pharma system needs a little ass kicking from time to time, like all process based businesses. This may be the start of a new set of studies and disciplines. IMO.
IMO, Dr.M. and AVXL team are basically taking the left seat, PIC.
Recent AVXL News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
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- 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
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- 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
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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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