Saturday, July 04, 2020 9:39:57 AM
I agree w/this post in terms of direction (nominally positive business move) and emphasis...(REMAIN IN BUSINESS). I would expand and add to that line of thinking. (what's next? we have only scratched the surface on CNS Cellular Homeostasis possibilities) We want to declare victory, but, we have just learned (acquired) some critical new CNS scientific facts from this trial which must be taken further. So, our portfolio of things we know we do not know just got a lot bigger and we must evaluate further. The growth of new knowledge must continue and AVXL are the best qualified set of resources to do that. IMO, that is what he is doing, he is building a longer runway.
We know that FDA (and other models)-TRIALS processes have failed in the past w/the PASS/FAIL ( 1 or 0) one or zero thinking. Past trials rules are (by design) constrained to single shots. Recently, Some New rules show promise for partial success or use while it gets clarified, etc. We start to see terms like QOL -Quality of life- RWD-RWE being used. All good stuff but it is still a form of PASS/FAIL as far as WS-REGULATORS-insurance companies-politicians are concerned and their set of rules drives everything. Well, guess what, that is just wrong thinking and it gets us what we have seen in some CNS solutions (Homeostasis-Autophagy).
We see some (like BIIB) who get themselves all tangled up w/redoing the numbers to get trial approvals. Very sad. All B/C the process is what it is and it's broken. It rewards chasing a symptom but does not punish for any toxic (unintended wink-wink, nudge-nudge) side effects. In fact the current process allows the developer to simply get creative and write a label that allows them to sell it while the warning label is telling users to be careful. (it's all good) That has been defined as a (WIN-WIN) under current rules. There are also other unspoken conditions which everyone remains silent on. Years later, These develop when some body function or organ becomes damaged/stops/malfunctions b/c of undetermined toxic side effects...this is knows as the OOOOPS-labeling clause (legal action follows). So, the current process is a closed loop as long as you do not wonder if the science couldn't do better.
So, this (AVXL LPC) deal supposes a different process goal. What if we looked at the trials process as a continuous learning trial/opportunity. One that can produce valuable scientific data/products but also keeps on going to complete the learning process.
This is a condition where we get good(pass) trial results (BUT-AND) we develop new knowledge from the trials which we want/are compelled to follow up on. (why do we always have to go back and start at zero again?) This is certainly the process required to fully understand the benefits of CNS Cellular homeostasis. (it's complicated) It has to keep going, IMO. That is why he is cutting this finance deal. Brilliant. But according to the current rules we are obligated to do the pass/fail thing. NOW WHAT??. Technically, you have passed the trial but you want to continue on w/most/all of the same patients. As they live their NEW NORMAL lives. W/new goals-criteria.
AVXL have applied Precision Medicine methods and rules and (I claim) they have a lot more runway left but the rules say...(IT'S GOOD ENOUGH) . What do you do? And while you are thinking about the answer you must deal with how to close the existing trials as they have winners. BTW, you will gonna run out of runway and money some day.
The current trials processes may inadvertently constrain continuous application of the CNS Cellular Homeostasis thesis science development. It gets better, because it is getting better
How about getting more big money to sustain ops while you do both market the just approved treatment and continue on with the new knowledge and planning for an even better CNS treatment. Remember CNS diseases present many unplowed fields of continuous opportunity. Lets not be constrained by a trials process that does not meet our needs. There must be a way we can have our cake and eat it too. It looks to me like the current trials rules never contemplated CNS CELULAR HOMEOSTASIS AND THE CONCEPT OF CONTINUOUS IMPROVEMENT. We now know that life does not work that way, it is a continuous flow, it ain't over til' it's over.
https://www.knowablemagazine.org/article/living-world/2020/single-cell-studies?utm_source=twitter&utm_medium=post&utm_campaign=originals&fbclid=IwAR0XhoBZ7XaX5FkuyoTSixFfbRcalytpl0RTtpoz7Z7qdydU09Ozjg0vQ0g
Summary, you write some new rules of how to have your cake while you are eating it.
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 Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • Jun 14, 2024 2:07 AM
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Snakes & Lattes Opens Pop-Up Location at The Wellington Market in Toronto: A New Destination for Fun and Games - Thanks 'The Well', PepsiCo, Indie Pale House & All Sponsors & Partners for Their Commitment & Assistance Throughout The Process • FUNN • Jun 13, 2024 8:18 AM
HealthLynked Introduces Innovative Online Medical Record Request Form Using DocuSign • HLYK • Jun 12, 2024 8:00 AM
Ubiquitech Software Corp (OTC:UBQU) Posts $624,585 Quarterly Revenue - Largest Quarter Since 2018 • UBQU • Jun 11, 2024 10:13 AM
Element79 Gold Corp Files for OTCQB Uplisting, Provides Financial Update • ELEM • Jun 11, 2024 9:25 AM