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WOW,
An excellent example of how all the pieces/work done by/ for AVXL WW (RWE-RWD) using precision systems are for connecting the AD-CNS ( AI SYSTEMS) DOTS . Well done georgejji.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.arianapharma.com/wp-content/uploads/2019/03/ANAVEX2-73_CTAD_2018_Presentation_v2.pdf
Thx for the suggested edit...But, where I come from , what I typed is functionally equivalent ...."famous comment by (...then U.S. President ) Ronald Regan..., to former US President ... " There's a Pony in here somewhere."
Thx anyways....
Foodman1291,
Thank you, I do appreciate your generous comments. BR,
When wondering about AVXL, I am often reminded of the famous comment by (then U.S. President ) Ronald Regan..., " There's a Pony in here somewhere."
W/all respect to both posters and all readers: We are sharing clinical results and assessing them . These are CNS diseases that have never had solutions. Subjects may get/recover some function/other back to establish a ,"new normal". "We do not know, what we do not know...YET" (Senge). Lets be cautious and be open/prepared to learn something new. This recovery process may go on for a long time. My meaning was that the effect of blarcamesine -- having reached its maximum value at four weeks -- held steady, and the increase we see thereafter is an increase in the placebo effect that precisely matches the placebo increase seen in the placebo arm.
LarryMexico28
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[quote ]Missling hangs in till July of 2025 as the stock limps around, gets fired and then new guy touts 3-71 and the swindle runs on[/quote]
Just need TGD to show proof of positive direction with respect to RETT and AZ. The $14 Billion buyout of Karuna establishes the AVXL target. C'mom TGD, show us the way! WGT
[color=red]
"Missling's (decision) processes makes it damn hard to have faith in the company."-plexrec
123tom...
It has a chance but the price action we're looking at these days is the bleeding down game.
With the introduction of AI into trials sloppy science won't be enough to get drugs approved.
The people pumping toxic treatments are going to have to change their game.
XenaLives I'd rather see AVXL as a dominant entity in drugs that treat CNS and other disease on a molecular level.
OK w/me....BUT ...but (in my VERY LIMITED thinking) AVXL is leading an awakening-discovery process in CNS BIO-Med diseases causal links. I am not Bio-qualified to define/describe the discovery process but I have seen such in my past in semiconductor device physics development physics-engineering. In fact after 40+ years that learning process is still evolving. IMO, the same principals or /+/- new learning apply here also. The big difference is semiconductors present a harder science (trial-error certainty) vs medical-bio learning fields of unknown-unproven variables. FDA needs to refine that model and help everyone to move on for the sake of humanity, IMO.
I do agree that AVXL is presenting the brightest CNS diseases light (by far) .
sage4
What a mess.
Not sure about other longs, but a $14 billion AVXL buyout today makes sense to me.
WGT!
“Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” CEO Chris Viehbacher said in the company’s statement.[?]. Another lesson from that old book..."You can't shine Shat".
XENA
CNS is being diagnosed and treated based on false biological premises...
The same is true for many other diseases. There is an old Irish expression (it's great)...."Unconstrained by knowledge, we moved on."
XENA ...When you go to the doctor and pay for that appointment you deserve more than a crap shoot.
Break the bubble of serial thinking . CNS diseases present complexity which will not be solved (unless someone get very lucky) looking at one variable at a time. Huh, no WONDER it has been stuck in Amyloid spot thinking for so long.
"As a biopharmaceutical Company with a proprietary late stage pipeline for CNS indications, Anavex brings expertise in precision medicine drug development to the partnership and we are excited to collaborate with Partex and fully leverage AI to expand beyond our R&D into healthcare sales marketing to bring better treatment options to patients in a patient centric way,” said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
https://www.anavex.com/post/anavex-life-sciences-and-partex-group-announce-strategic-partnership
powerwalker
Today, one of these folks told her that a big issue for those with sleep apnea are highly susceptible to Alzheimer's as the apnea reduces the oxygen getting to the hippocampus, which results in its shrinkage.
123tom...? does the after hours pop in AVXL signify anything to you, or is it just noise? (6.39
+0.10)
(+1.59%)
After hours: 4:35 PM EST
S1R will lead our way out of the AD systemic wilderness. ...AVXL is step one.
WOW, excellent work here. As we have discussed here, "It's ABOUT THE CNS...SYSTEMIC INTERACTIONS are key ".
Podcast Overview
Dr. Mark Hyman and Dr. Dale Bredesen, experts in functional medicine, discuss root causes of Alzheimer's. According to them, the cause of Alzheimer's is extremely individualistic and is a culmination of many years worth of toxic buildup. Examples of root causes include vitamin deficiency, leaky gut, incompatible microbiota, heavy metal toxicity, oral bacterial encroachment, herpes, molds in the sinus, and more. All of these root causes route towards a similar pathology in all Alzheimer's patients, including plaque formation (which may be our brains trying to fight off these toxins), inflammation, and catastrophic cellular failure/brain matter deterioration.
Ethics of placebo in children
The use of placebo in children is more restricted than in adults, because children cannot consent. Placebo should not be used when it means withholding effective treatment, particularly for serious and life-threatening conditions. The use of placebo is often needed for scientific reasons, including pediatric trials. The use of placebo may be warranted in children as in adults when evidence for any particular treatment is lacking or when the placebo effect is known to be very variable (e.g., pain, hay fever). As the level of evidence in favor of an effective treatment increases, the ethical justification for the use of placebo decreases.[24]
So what happened with your RA?
WOW...the CNS pieces are falling (linking) into place...
https://www.anavex.com/post/anavex-life-sciences-appoints-former-fda-lead-neurology-statistician-as-vp-head-of-biostatistics.
“I’m honored to be joining Anavex and I am very much looking forward to helping guide the Company to secure access to better healthcare outcomes for families around the world,” said Dr. Jin. “There is such a significant unmet medical need around the globe caused by Alzheimer’s disease, Parkinson’s disease, and neurodevelopmental diseases like Rett syndrome and Fragile X syndrome. Anavex has a cutting-edge technology that can make a great deal of difference to those patients. I believe I can make a substantial contribution at this very important time in the Company’s transition towards commercialization.”
Parkinson's Disease
New Parkinson's Definition Proposed Based on Biomarkers
— Framework focuses on the biology of Lewy body diseases
by Judy George, Deputy Managing Editor, MedPage Today January 26, 2024
these are links to things we do not know we do not know...YET.
I had a similar (direct cause) link between an arthritis med (injection of prescribed HUMIRA) and serious repeats of Pneumonia . Asked my doc about the connection after reading a med journal article and multiple flares of serious hospital emergency flairs of Pneumonia . RA doc said NAAAHH no connection-denied causal connections exist---vowed after my last ER trip to stop Humira...guess what??/No more ER trips ...clearly was the cause due to some kind of lowered threshold, etc.
ALMOST killed me...multiple ER trips...publication was exactly right. Clinics get paid bug $$$ to feed the monkey. If I had not seen the Med Pub (and taken action) I would be dead.
Expect great news Monday. This is MM shenanigans. Close at the low to scare the longs. They always know.
Thanks powerwalker..one wonders ... how long will this go on?
Appreciate and value this insight.
Any (fact based) rational thoughts on what is driving AVXL sp down today? Looks like some kind of change-news?? TIA
Thanks...
Hosai, please fwd a link described in your post. I am not seeing access!
At the JP morgan conference at minute 31 and for slide 26 Missling stumbles over his words a bit but essentially says this - "we also want to point out the seperation between oral once daily liquid solution for the rare disease franchise, and the oral solid administration for the alzheimers pathology and parkinsons pathology. So we can very nicely seperate those two franchises with different doses aswell as different branding".
TOLD YA...Precision Med follow up...WOW....getting closer...very , very nice...getting closer to the next level discussion and accelerated problem solving models...
Recent genetic research has identified connections between schizophrenia and Alzheimer disease, suggesting shared mechanisms between the 2 disorders. Notably, a successful trial of Karuna Therapeutics’ dual M1/M4 muscarinic receptor agonist, KarXT (xanomeline-trospium), in individuals with schizophrenia has shown efficacy in treating both positive and negative symptoms,1 leading the FDA to grant the treatment a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.2 Muscarinic agonists have been explored in the context of Alzheimer disease and schizophrenia in previous studies.1
“Schizophrenia is a serious mental illness affecting 24 million people worldwide,” said Christopher U. Missling, PhD, president and chief executive officer of Anavex Life Sciences Corp, developer of Anavex 3-71, in a press release. “While current antipsychotic therapies can be effective in managing positive symptoms, like hallucinations and delusions, they may not fully address persistent negative symptoms or cognitive difficulties. Often, available treatments are limited by side effects, eg, movement disorders, sedation, weight gain, and other metabolic side effects.”
Research shows that approximately 30% of individuals with schizophrenia to not respond to therapies, and additional 50% either experience intolerable adverse effects or only experience partial improvement in their symptoms.1
To address all of this, Anavex aims to leverage its Precision Medicine Platform by studying Anavex 3-71 alongside blarcamesine (Anavex 2-73), an orally available drug candidate that reestablishes cellular homeostasis by targeting muscarinic and SIGMAR1 receptors. The company is studying this combination of drug candidates in order to offer potential treatment options for Alzheimer disease and schizophrenia.1
Anavex 3-71, with its selective SIGMAR1 receptor activity, presents a new pharmacological approach to address disruptions to neuronal homeostasis observed in individuals with schizophrenia. This is expected to complement existing treatments that do not comprehensively cover all symptom domains in schizophrenia.1
https://www.psychiatrictimes.com/view/drug-candidate-for-schizophrenia-alzheimer-disease-approved-to-initiate-phase-2-trial-in-q2-2024
HMB2010...THANKS FOR this post-link...WOW...all good...MASSIVE POSITIVE
https://www.psychiatrictimes.com/view/drug-candidate-for-schizophrenia-alzheimer-disease-approved-to-initiate-phase-2-trial-in-q2-2024
Blackrock went from 6,061,191 to 6,675,075 shares. That is up 613,884 from last reporting period. They might know more than we do. https://archive.fast-edgar.com/20240125/AWVP2G2CZ22JSZZ2222F2ZZBAORLZZ22W262/us0327973006_012524.txt
This PR suggests the FDA redo:
(Recently in June 2023, Anavex Life Sciences announced that all participants had been dosed in the placebo-controlled phase 2/3 EXCELLENCE (NCT04304482) study assessing blarcamesine, a small-molecule activator of sigma-1 receptor, in pediatric patients with Rett syndrome.3 The trial, which features 92 pediatric patients with Rett syndrome, aged 5 to 17 years old, is a multi-center, double-blind trial assessing the safety, tolerability, and efficacy of the therapy, otherwise known as ANAVEX 2-73.
After discussions with the FDA, EXCELLENCE plans to use the RSBQ total score and CGI-I as coprimary end points. Effects on these end points will be calculated through a statistical analysis plan that includes specified linear mixed-effects models for repeated measures. "We are looking forward to the topline data from the EXCELLENCE phase 2/3 ANAVEX2-73-RS-003 Rett syndrome pediatric clinical trial in the second half of 2023,” Missling said in a statement.1).
Tells us again that , since FDA does not have or understand clinical evidence of RSD Root Cause they default to STATSPEAK to get guidance on what to do next?? Sound familiar?
.the next move up which is not that far away needs to be with conviction, that implies big price push & volume