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crescent? Any insights (biostat source) on AVXL-OLE PDD results? TIA.
All anyone needs to know. Ever wonder why they even have this conversation?
HOW DOES THE NEW DRUG WORK?
https://apnews.com/article/health-medication-b42dc8b32d71f1b6892b07d85e0e7da0
The drug, made by Japan’s Eisai and its U.S. partner Biogen, is designed to target and clear away a sticky protein called beta-amyloid that builds up into brain-clogging plaques -- one key hallmark of Alzheimer’s disease.
It’s a long-needed new treatment, but experts also are voicing a lot of caution: The drug isn’t a cure, it’s only intended for early-stage patients, requires IV doses every two weeks, and comes with some safety concerns.
IMO, AVXL must present multiple RWE/RWD clinical trial cases. These should be realistic, verifiable, convincing factual summations linked w/human results from the AVXL treatments. I have long believed the RSD cases would provide strong evidence of (Before-After) credible and medically demonstrative change tied to treatments. Prove we have the truth and move on w/o fear.
The liars and the thieves must be outed.
Corruption may involve many activities which include bribery, influence peddling and the embezzlement and it may also involve practices which are legal in many countries. Political corruption occurs when an office-holder or other governmental employee acts with an official capacity for personal gain.
Corruption - Wikipediahttps://en.wikipedia.org › wiki › Corruption
AN "AHHHAAA" moment: thx again from XENA
A doctor speaks about the approval process for Alzheimer's drugs...
https://www.facebook.com/DrScottJensen/videos/2518157701675288
Xena...WOW...Thanks.
Xena
A doctor speaks about the approval process for Alzheimer's drugs...
https://www.facebook.com/DrScottJensen/videos/2518157701675288
crescentmotor
Yes--but my point was centered on in what regulatory juridiction(s) should AVXL initially file for drug approval. It may well be that some jurisdictions may facilitate/hasten the regulatory approval process whereas other jurisidictions may, for whatever reason, throw up delays or even roadblocks. AVXL needs to test the water temperature before making the huge, time-consuming commitments that will be required. I am actually hoping the release of full data will trigger action by one or more of the regulatory jurisdictions.
This would be laughable if the disease was not so serious.
FDA approves Alzheimer’s drug shown to moderately slow cognitive decline in early stages of the disease
Adam Feuerstein
By Adam Feuerstein
https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/
Same Ole, Same Ole...FDA is embarrassing itself...SAD REALLY SAD.
Researchers evaluated Leqembi’s efficacy in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer’s disease. Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. Patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.
These results support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease. Amyloid beta plaque was quantified using positron emission tomography (PET) imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expected to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.
The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur. ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure. Another warning for Leqembi is for a risk of infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure. The most common side effects of Leqembi were infusion-related reactions, headache and ARIA.
AVXL gets positive mention in the middle of the smoke...
Caring for patients with Alzheimer’s and other diseases costs the country over $320 billion in 2022 alone. Due to an aging population, these figures are projected to reach $1 trillion by 2050 – unless scientists discover a game-changing treatment.
The Michael J. Fox Foundation for Parkinson’s Research has been one of the leading supporters of research in the field for years. Among other projects, the foundation supports small, innovative biopharmaceutical companies researching potential treatments for Parkinson’s Disease Dementia (PDD) and related conditions.
One of the foundation’s recent research grants was awarded to New York-based Anavex Life Sciences, a company whose scientists are working on a drug to treat PDD, Rett syndrome, and other forms of dementia as well as rare diseases that impact the central nervous system. Known as ANAVEX®2-73, the drug binds to the sigma-1 receptor in a patient’s brain and spinal cord and stimulates it.
Research has shown that dementia patients have fewer of these receptors than their healthy counterparts. By stimulating the activity levels of existing sigma-1 receptors, ANAVEX®2-73 looks set to protect the health and function of nerve cells, thus reducing the symptoms of various forms of dementia. The foundation’s grant fully funded preclinical work and the drug candidate has since successfully moved on to advanced clinical trials.
From the beginning, Anavex’s approach to its research and trial phase had digital technology at its heart. The goal was to streamline the research process and shorten the time between laboratory and patient without compromising research integrity and quality.
JWC3?
Has Medicare said that the FEDs are going to ante up for these BB&BS infusion shots?
The FDA has been OUTED. The process of validating AMYLOID causal links to AD and other indications has been claimed (some say proven) to be dangerously flawed. GAME OVER. AVXL portfolio is well established science w/strong trials evidence of efficacy. (No smoke and mirrors, it is all real). FDA are locked in dark rooms of CNS diseases denial. (GAME OVER>>>AND YOU KNOW IT)
https://www.thefp.com/p/where-is-the-cure-for-alzheimers
WOW, FINALLY a PAPER that calls out all the AD AMYLOID Thesis history and correctly identifies why no AD treatment has come from research to date.
WOW...GREAT NEWS. Entirely consistent w/the struggles Dr.M. and staff have been against.
This paper should be required reading for every serious AD-MED investor....JUST EXCELLENT STUFF. Finally .
W/any luck this kind of publication will help others to listen w/an open mind and to study the AVXL MOA upstream hypothesis while they follow the science and trials proof.
EXCELLENT STUFF.
hnbadger1
Let’s see what next week brings.
Remember this : Something will be said/done: IMO: THE FDA has some SPLAINEN TO DO:
https://www.thefp.com/p/where-is-the-cure-for-alzheimers
WOW, FINALLY a PAPER that calls out all the AD AMYLOID Thesis history and correctly identifies why no AD treatment has come from research to date.
WOW...GREAT NEWS. Entirely consistent w/the struggles Dr.M. and staff have been against.
This paper should be required reading for every serious AD-MED investor....JUST EXCELLENT STUFF. Finally .
W/any luck this kind of publication will help others to listen w/an open mind and to study the AVXL MOA upstream hypothesis while they follow the science and trials proof.
EXCELLENT STUFF.
The next few weeks are going to be a little tricky around here. WGT.
Maui...Never underestimate the power of prayer. Be well.
This a good start but we have a long way to go yet....NICE to see.
Analysts at HC Wainwright raised their price target on Anavex Life Sciences (NASDAQ:AVXL) to $50.00
Once the word on AVXL trails data begins to get assessed and the results do FINALLY get published by competent science folks (both in academia and WS) a new wave of confidence will evolve quickly as investors begin to truly trust what they are being told. MARK THIS DAY.
https://beststocks.com/analysts-at-hc-wainwright-raised-their-price-targe
hnbadger1
This is gaining traction! Talk radio host Erick Erickson just did a segment on this on his show today. He talked about the time has come to move in a different direction in AD research!
Perfect timing for Anavex!
georgejji,
https://www.thefp.com/p/where-is-the-cure-for-alzheimers
Several scientists described those who controlled the Alzheimer’s agenda as ‘a cabal.’ In more than two dozen interviews, scientists whose ideas fell outside the dogma recounted how, for decades, believers in the dominant hypothesis suppressed research on alternative ideas…This stifling of competing ideas, say a growing number of scholars, is a big reason why there is no treatment for Alzheimer’s.
https://www.thefp.com/p/where-is-the-cure-for-alzheimers
WOW, FINALLY a PAPER that calls out all the AD AMYLOID Thesis history and correctly identifies why no AD treatment has come from research to date.
WOW...GREAT NEWS. Entirely consistent w/the struggles Dr.M. and staff have been against.
This paper should be required reading for every serious AD-MED investor....JUST EXCELLENT STUFF. Finally .
W/any luck this kind of publication will help others to listen w/an open mind and to study the AVXL MOA upstream hypothesis while they follow the science and trials proof.
EXCELLENT STUFF.
plex
"4th death from lecanemab?"---and this drug is being considered for approval ?? If it is approved may the FDA be
Wishing all here the best 2023. Some here have family impacted directly by AD, we have no better friends than AVXL.
Brings to mid an old U.S. MARINE CORP theme..." No better Friend, No worse enemy". Bless them all.
IMO, when the AVXL flips (today?) and turns up it will go straight up for a long time...we earned it.
FDA has built a house of Cards based on an AMYLOID PLAQUE Thesis, which they failed to prove after 20+ years and billions$$, etc. They have become their own worst enemy and now find themselves with, "Double Secret Probation", options. They must either reject the AMYLOID Thesis (will not happen) or extend the plan w/"DO OVERS"...that stretch over the horizon.
The AVXL multi national-multi conditional MOA based program has been much more complicated than it needed to be to prove the (Y/N) science. The corrupted-political- BP-FDA machine has failed to produce an effective-viable, legitimate -fact based solution. (GAME ON HOLD- OR OVER?) FDA can either keep trying to force it down our throats OR... call a time out. IMO, they cannot win B/C the science is not there and they are out of delays, lies/cover ups. People are still dying and IT'S ALL ON THEM.
Thanks Talon. All the best .
Talon38
anyone with a brain would give a negative evaluation to the amyloid plaque approach
The FDA must see that, and it's decision will either increase or diminish it's credibility.
https://endpts.com/congressional-inquiry-into-highly-atypical-fda-biogen-ties-ends-with-damning-report-no-repercussions/
Well Done . This publication suggests a clear link between the FDA and any BP firm on the Amyloid Plaque path to CNS disease Nirvana. That path goes straight off a cliff, as AVXL will again demonstrate soon (IMO).
IMO, we are witnessing a herd experience brought about by (soon to be) acknowledged collapse of the FDA-Amyloid Thesis solutions as smart owners run for the hills. Not only is AVXL not on the Amyloid CNS causal path but we are on multinational multiple trial paths w/associated linked-validated regulatory bodies and research organizations. That has been our strategic plan. Yes, this plan has been difficult but we can now witness the benefits.
IMO, when this next AMYLOID shoe drops every CNS Disease shareholder will massively abandon the AMYLOID Causal Thesis fleet. ......AVXL will say..." WELCOME ABOARD".
"Pilots and crews , report to your Ready Rooms".
attil
"Dr. Missling is operating at his own pace as he always has. I expect he's going to make the next data release as bulletproof as possible,
Mikesc
I am guessing TGD releases the data after the FDA decides BIIB's faith with their new drug. Whether they approve or not he can make the comparison between the two drugs. A MIC DROP MOMENT!
The biggest science issue here on AD has been the confidence levels assigned or assumed on what and HOW to measure AD treatment efficacy. IMO. FDA and BP have been stabbing in the dark for decades to demonstrate the causal links to Amyloid plaques . AVXL have gone on a different path and, we look to be close to be recognized as the winner. Bottom line (IMO) is ,will FDA FINALLY admit their Amyloid HORSE HAS DIED?
Dr.M. and the AVXL team are about to be recognized as winning rounding the clubhouse turn...heading to the finish line (BTW) we got RSD AND others along w/AD. Everybody WINS.
The GOOD NEWS IS...(IMO) now, AD and other CNS disease will be properly assessed (eventually). AND,, the FDA will FINALLY be redirected to research and spend on AD-CNS things that matter. That will be traumatic.
It’s not unambiguously clear whether lecanemab meets the litmus test CMS imposed, namely answering the question CMS posed in the NCD in the affirmative: “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”
Also, even if CMS relaxes restrictions, in the end lecanemab’s uptake will also hinge on whether physicians and patients find the data convincing. For example, while some clinical neurologists believe the data posted by the sponsors is promising, others have said they do “not foresee much meaningful change in patients' lives.” For lecanemab, as for any medicine or healthcare intervention for that matter, statistical significance does not necessarily imply a meaningful drug to individual patients and their caregivers.
Never underestimate the power of prayer.
[/quoteBill Whitaker reports on the unexplained healings that have occurred at the Sanctuary of Our Lady of Lourdes in the south of France, and the team of world-renowned doctors and researchers who investigate the claims of cures.
]
I am absolutely certain that Roche is interested in partnering with or buying Anavex Life Sciences or licensing Blarcamesine from Anavex.
I have heard and believe that JNJ and Pfizer among other big Pharma are also interested in Anavex Life Sciences.
Happy new year and GOD bless,
This is looking like Ad-101 (How to...blank, then if BLANK...). Not a good look. Maybe we can all buy kits for "HOW TO..."...
Good luck w/that. Count me out
https://news.bloomberglaw.com/health-law-and-business/drugmakers-are-testing-ways-to-stop-alzheimers-before-it-starts
Thx...BUT, we should note the AXX covering text from the PR. This is code for a very sloppy process review was conducted...(NOTE: N.J. IS home base for BP in USA.)
The FDA, in a statement, said the “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”
Biogen, in a statement, said it “stands by the integrity of the actions we have taken.”
FDA process findings: The committees’ review of the FDA’s and Biogen’s interactions over nearly two years found that an internal agency review concluded that the FDA’s work on a briefing document with the drugmaker ahead of a November 2020 advisory committee meeting “was not an appropriate approach” given the lack of consensus within the Office of New Drugs on the regulator’s position. Advisers overwhelmingly voted against recommending Aduhelm’s approval.
Committee staff obtained documents showing that FDA staff and Biogen officials held at least 115 meetings, calls and “substantive email exchanges” from July 2019 through July 2020. The agency acknowledged that the total number of meetings in that timeframe is unknown because the FDA lacked a “clear record” of informal interactions between regulators and the drug sponsor.
The FDA in its statement pointed to an internal review that found the actions were appropriate, and said the agency has already started implementing changes consistent with the committee’s recommendations, including examining the use of a joint briefing document.
“While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA,” Energy and Commerce Chair Frank Pallone (D-N.J.) said in a statement.
The FDA, in a statement, said the “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”
Biogen, in a statement, said it “stands by the integrity of the actions we have taken.”
House Dems raise issues with ‘atypical’ FDA review process for Alzheimer’s drug
A GREAT INVESTIGATION FROM THIS HOUSE COMMITTEE
https://www.politico.com/news/2022/12/29/fda-review-process-alzheimers-drug-00075675
Thx...BUT, we should note the AXX covering text from the PR. This is code for a very sloppy process review was conducted...(NOTE: N.J. IS home base for BP in USA.)
The FDA, in a statement, said the “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”
Biogen, in a statement, said it “stands by the integrity of the actions we have taken.”
FDA process findings: The committees’ review of the FDA’s and Biogen’s interactions over nearly two years found that an internal agency review concluded that the FDA’s work on a briefing document with the drugmaker ahead of a November 2020 advisory committee meeting “was not an appropriate approach” given the lack of consensus within the Office of New Drugs on the regulator’s position. Advisers overwhelmingly voted against recommending Aduhelm’s approval.
Committee staff obtained documents showing that FDA staff and Biogen officials held at least 115 meetings, calls and “substantive email exchanges” from July 2019 through July 2020. The agency acknowledged that the total number of meetings in that timeframe is unknown because the FDA lacked a “clear record” of informal interactions between regulators and the drug sponsor.
The FDA in its statement pointed to an internal review that found the actions were appropriate, and said the agency has already started implementing changes consistent with the committee’s recommendations, including examining the use of a joint briefing document.
“While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA,” Energy and Commerce Chair Frank Pallone (D-N.J.) said in a statement.
The FDA, in a statement, said the “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”
Biogen, in a statement, said it “stands by the integrity of the actions we have taken.”
plexrec:
"lowlife corrupt..."..absolutely correct...
Internal clashes caused last-minute chaos at the FDA
There were substantial internal disagreements over Aduhelm between two parts of the FDA: the Division of Biometrics, which does statistical reviews to ensure the safety and effectiveness of new drugs, and the Office of Neuroscience. The full extent of the dispute became apparent only about 10 days before an analysis for FDA advisers was due. FDA leadership scrambled, but ultimately weren’t able to fully resolve the disagreements before the presentation, and the analysis critical of Aduhelm was only included as the very last appendix in a more than 300-page report.
Collaboration between the FDA and Biogen was ‘atypical’
The FDA’s and Biogen’s joint preparation of a briefing document and a presentation for the FDA advisory committee meeting in November 2020 was unusual. It’s an approach that the FDA had previously used only nine times, investigators wrote, and never before in the neuroscience office. Generally, the agency’s and drug manufacturers’ analyses and briefing documents are separate and independent. By contrast, Biogen worked so closely with the FDA on the briefing document that it was difficult to distinguish between who wrote what, congressional investigators found.
MatoMo...
I like this Japanese spin-off alias you gave me.
MatoMo
My opinion regarding the outlook for Blarcamesine at the FDA:
I do not believe the review process will be slower (I don’t believe it will be faster either). However, with the new scrutiny on the FDA to provide drugs that are safe and efficacious, it seems reasonable to me that Blarcamesine very well may have just slid into the top contender over Lecanemab.
DoTheRightThing
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Also it's laughable you think "fudders" posting here, twitter, etc. actually moves the stock price. I think that was also previously explained to you, but it's like talking to a wall.