Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Excellent material here. New tool suite will/may actually add to CNS diseases overall scope/knowledge and complexity. BP is going to hate this. One Size does/may not fit all. AND, the social shoe horns in use must be shat-canned. IMO. Intelligence is a beautiful thing, even if it is artificial . We are all just @ the tip of beginning,, IMO.
HUH...https://alz-journals.onlinelibrary.wiley.com/toc/15525279/2023/19/S8
Retail AVXL holders need to rethink what ever (BUY/HOLD/SELL) price-time clocks you have running, IMO.
Anyone w/ some experience using/AI systems and the impact they may/might have on decisions would suggest the decision horizons can move as new reasoning-time lines become factors...(WAIT_SELL-BUY_ OTHER).
Expect that the new tools will likely introduce new variables and paths b/c their fields of data and decision factors . Some new variable paths may cause you to rethink what might have previously been/seemed obvious. One reaction may be that you will have new-more (what if ???) process questions to reason over than you typically do now.
It's all good, just stand back and rethink unintended possible consequences. This will be particularly true as the tool becomes more populated w/facts which you consider important but which you would have previously not even considered.
IMO, Dr.M. and staff may be spending a lot of time right now going through AI models-data being available and accuracy of data being used to reason over. Things/factors that previously (seemed) not have been in the decision pot may now show up w/various timelines attached. So, a quick obvious choice from the past may now take a lot longer, depending on data sources and the speed of the new AI system to respond to variables/questions.
bas2020
https://www.nytimes.com/2023/07/19/us/stanford-president-resigns-tessier-lavigne.html
Interesting Stanford U. findings. A key professor and AD academic leader has been determined to have been "at least" very sloppy in his area of responsibility ref AD reporting . Corruption and lies in academia are disappointing (to say the least). IMO, the AVXL WW team are much more insightful and valuable than we suspect they might be. We recognize that 50+ years is a long time to remain clueless as to AD cause. IMO, once we get the REAL-STORY (answer) many, many stories like this one will -may percolate to the surface, IMO. This should just NOT BE HAPPENING.
Any of us who have a sense that 50+ years of research in AD and still no solid published -proven proof of " root cause" ...HUH?? Dr. M is a low key guy, as he chooses . IMO< there is lot more of the same kind of academic outings in the future, once absolute proof of CNS diseases causes are proven. It may be that AVXL and AI methods and affiliations will be key to these future moments of truth.
Everyone...Keep the faith .
Nice Catch...
This guidance is what AVXL will/are providing. Anyone who has ever lead during systemic changes knows it is hard -time consuming painful work. Maybe that is why people avoid doing it. FDA process controls and disciplines are critical and required. The regulatory headset and making changes that work is tough to do, ask anyone who has ever had to do that.
IMO, that is what Dr.M. and his AVXL team are leading ...it's all about CHANGE ,it takes time. Sad to say.
Senge, P. (1990/2006). The fifth discipline: The art and practice of the learning organization. Doubleday.
] The fifth discipline: The art and practice of the learning organization
PM Senge
2006•books.google.com
Completely Updated and Revised This revised edition of Peter Senge’s bestselling classic, The Fifth Discipline, is based on fifteen years of experience in putting the book’s ideas into practice. As Senge makes clear, in the long run the only sustainable competitive advantage is your organization’s ability to learn faster than the competition. The leadership stories in the book demonstrate the many ways that the core ideas in The Fifth Discipline, many of which seemed radical when first published in 1990, have become deeply integrated into people’s ways of seeing the world and their managerial practices. In The Fifth Discipline, Senge describes how companies can rid themselves of the learning “disabilities” that threaten their productivity and success by adopting the strategies of learning organizations—ones in which new and expansive patterns of thinking are nurtured, collective aspiration is set free, and people are continually learning how to create results they truly desire. The updated and revised Currency edition of this business classic contains over one hundred pages of new material based on interviews with dozens of practitioners at companies like BP, Unilever, Intel, Ford, HP, Saudi Aramco, and organizations like Roca, Oxfam, and The World Bank. It features a new Foreword about the success Peter Senge has achieved with learning organizations since the book’s inception, as well as new chapters on Impetus (getting started), Strategies, Leaders’ New Work, Systems Citizens, and Frontiers for the Future. Mastering the disciplines Senge outlines in the book will:• Reignite the spark of genuine learning driven by people focused on what truly matters to them• Bridge teamwork into macro-creativity• Free you of confining assumptions and mindsets• Teach you to see the forest and the trees• End the struggle between work and personal time
Leading is hard work,, particularly when the people/industry/structure you are dealing with are entrenched (up to their eyeballs) in a wrongheaded thesis (CNS Amyloid system) . Change is tough-impossible, particularly when the issues we want to resolve involve regulatory bodies and (virtually) the entire BIO-MED-academic-practicing CNS universe believe something else. AVXL are working on WW systemic change models.
https://link.springer.com/referenceworkentry/10.1007/978-3-319-49820-1_100-2
The reality is AVXL are not only leading a new field of medical reasoning but we are simultaneously asking others to abandon much of what they currently believe. This is going to be complicated before we are done, but someone has to do it.
bas2020. Thanks for a well written and realistic assessment of AVXL strategy and implementation plans.
tsch...
bourban...
Anyone still wondering why Dr. M. just hired a bunch (most) of FDA tech senior leadership while he simultaneously partnered w/THE AI frat bros @Ariana. We might be looking for a new road map-skill set (not ole schoolers in WS) to start giving signals on the future of the W/S-BP-NIH-FDA compass.
Hey, it's what leaders do, they can't NOT LEAD. NICE, IMO. ...BTW, looking like the FDA crew were fully on board w/the plan. NICE.
abew4me
tredenwater2
You might consider the ignore option..
A key point for me is the precision and (so far) unqualified (sub-micro) trial wins. The upstream thinking and mini- links to solid interim results are strong indicators to me of a discovery process done well. No smoke and wizards flashbacks to grand Amyloid thesis, just solid connecting the dots. IMO, this is all about the process of learning which not only takes time but has multiple (wake up screaming) moments. Had Dr.M. taken the Amyloid herd path b/c he had the data to rationally warrant such then we (as investors) would all be dead by now,, IMO.
IMO, the fundamental "Upstream" thesis is critical to continuous testing of the MOA thesis. So far ....no reason to second guess , as we have witnessed others doing. The evidence of CNS reversals is mind blowing. God does not let that happen unless you have earned it...IMO.
pogue
Xenalives
8.98 +0.53 (+6.25%)
Pre-Market: 08:10AM EDT
Thoughts on why AVXL premarket is +++?
That is why ihub have an ignore function.
Everyone...deep breaths....breath through your nose. Good to go.
georgejji: GET READY!!!
READY FOR VOLUME!!!
OK...WHEN???
But it’s all in good fun to pass the time!
Just absolutely great entertainment.
powerwalker
Red, I agree that the pediatric results will be fantastic, which will explain the support for blarcamesine from the Rett community.
Pallotti
This article should receive a high level of acceptance within the FDA evaluators and the broader medical community.
[Thumbs up./quote- powerwalker ]
Flashback..."all hands...Prepare the flight deck for Air Operations..." . The ship is turning into the wind.
read this re peer reviewed criteria being met, pending admin details...otherwise , looks good to go.
The New Big Is Small: Leveraging Knowledge from Small Trials for Rare Disease Drug Development - Blarcamesine for Rett Syndrome
Ene I. Ette, Emmanuel O. Fadiran, Christopher Missling, Edward Hammond
First published: 10 July 2023 https://doi.org/10.1111/bcp.15843
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/bcp.15843.
PDFPDF
Abstract
Big data in drug development may not satisfactorily address the demands of precision medicine in a rare disease population, making the use of smaller clinical trials necessary. Consequently, the use of innovative design and analysis of these clinical trials using model-informed approaches have become indispensable. This requires informative exposure-outcome analysis, together with formal statistical analysis, which should include the strength of evidence for a study outcome. We demonstrate how knowledge can be gained, with supporting strength of evidence, from a small (data) clinical trial with a low dose of blarcamesine in the treatment of Rett syndrome (RTT). Based on a small data paradigm, pharmacometrics item response theory modeling and Bayes factor analysis were used to show that blarcamesine is efficacious in RTT.
Peer reviewed article?
mauismart, welcome back, well done. Stick around.
I bet alot of you were just waiting for me to come back and give you my lunch menu. Anavex just needed a little push today.
$8.66 +0.50 at the close of trading 4:00 PM EDT- georgejji
Bid: $8.24 x 60
Ask: $8.67 x 300
Volume: 1,047,017
Previous Close 8.16
Open 8.14
Bid 8.28 x 800
Ask 8.28 x 800
Day's Range 8.14 - 8.32
52 Week Range 7.44 - 15.24
Volume 85,472
Avg. Volume 943,177
Is todays trade volume (slow/low) ? Ab-e-normal? Any Thoughts on why?
plexrec
Dr.Kun Jin Phd--quote--" I believe I can make a substantial contribution at this very important time in the Company’s transition towards commercialization.”---does the dr. mean this or is he just pumping ???? You decide !!!
Special Access Program (SAP) applications are granted at a physicians’ request on behalf of patients. Based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that the study drug will continue to benefit patients, Anavex will continue its responsibility to support patients post study by facilitating the supply of ANAVEX®2-73 (blarcamesine) to patients in Canada. Approved compassionate programs are also ongoing in the United Kingdom and Australia, representing all regions of the Rett Syndrome study participation.
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs/guidance.html
schmiggins
"When this is over, you'll look back and what I've done will make sense." I know that's easy to say (and perhaps a bit egomaniacal!) but I think I see evidence that that will be the case. And gathering evidence is what it was all about. And I think they've gathered enough now. I think it was about discovering in what "patient" or just human "situations" does kicking in or kicking up the Sigma1 thing cause a real benefit for certain people and situations.