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What happens when the FDA is finally forced to admit that the amyloid Plaque AD causal thesis has not been proven (after 30+ years)? If everyone has to do a mid air restart (or die) ...then what??
We recognize the discipline, process structures and process skills required to manage a regulatory body must continue...but...where will they begin when the AD causal thesis has been finally-totally buried? Will the future be AI-science driven using precision medicine disciplines or will current BP practices keep continue.
Lets all hope this is the start of a legitimate science investigation into the entire Amyloid Plaque scam where trial results do not support the AD claimed Amyloid thesis and yet it was repeatedly allowed to continue as the legitimate causal root . IMO, there is a very dark-deep money pit here.
What could possibly go wrong???
The latest Lilly trial results gives a partial explanation..."they ran out of WHAT???"
https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html
Avxllent:https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html
Beginning to Question When This Happens?
https://finance.yahoo.com/news/fda-rejects-accelerated-nod-lillys-175205484.html
this link-attribution was missed from a msg I posted earlier...my bad.
This pr from today has a few key clues IMO. AVXL is (IMO) competitive in trials w/other international BP.
The AD target market is highly competitive as several other pharma companies like Anavex Life Sciences AVXL, Biogen BIIB and Roche RHHBY have their drugs targeting the AD indication. The Alzheimer’s drugs of these companies have either recently been approved for use or are in late-stage development.
Earlier this month, the FDA approved Biogen/Eisai’s Leqembi (lecanemab) under the accelerated approval pathway for the treatment of early AD. The approval was based on data from a mid-stage study which showed that treatment with the Biogen drug reduced the accumulation of amyloid beta (Aß) plaque in the brain. Biogen/Eisai priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year.
Last November, Rocheannounced the failure of the GRADUATE I and II studies, evaluating its monoclonal antibody gantenerumab in early AD. The studies failed to meet their primary endpoint of slowing clinical decline. Patients treated with Roche’s gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II, which was not statistically significant. Per Roche, the level of beta-amyloid removal was lower than expected.
Last month, Anavex Life Sciences reported positive topline data from a phase IIb/III study on its lead pipeline candidate ANAVEX 2-73 (blarcamesine) in AD indication. The ANAVEX 2-73-AD-004 study achieved its primary and key secondary endpoints. Data from the study showed that study participants who received ANAVEX 2-73 were 84% more likely to have improved cognition than those who were administered a placebo. Patients treated with ANAVEX 2-73 were 167% more likely to improve function than those receiving a placebo. The treatment also showed a statistically significant reduction in cognitive decline at the end of treatment by 45% compared with the placebo.
A 27% improvement compared to placebo in the CDR SB score at just 48 weeks for Anavex’s blarcamesine is better than EISAI’s/Biogen’s lecanemab at the same time point.
McM...
They have no plaque but they have not stopped the disease.. barely slowing it..
It doesn’t work!...BECAUSE...
The plaque is an outgrowth of the disease
not the disease..
I start my day with the sword at hand, ill lay it down when I die.
"The Pen and the sword, in accord".
What video? Where is the link? Thank you.
After watching tis video I am even more convinced that AVXL upstream S1R model will show important PDD clinical-treatment data and direction for those who suffer w-PD/PDD. IMO, there probably is no CNS silver bullet but getting on the right path starts w/A2-73.
It’s like we are in quiet period until peer review...McM.
Blessings to you as well treden
parks79
preparing data and pushing toward AD and Rett approvals this year to facilitate partnerships and commercialization, in order to fund PD, PDD, Fragile-X and other trials without further dilution.
sokol
If Blarcamesine works well with APOE3 patients, Anavex will focus on those APOE3 patients. This too would be highly significant in seeking approval in Asia. APOE3 is the most common among all human populations. Interestingly, its frequency varies throughout the world. Most interestingly its frequency in Asia seems to be the highest - 85%. ! APOE4 is relatively high in Australia, but highest in Central Africa.
sokol
It will also be interesting to see how the EU regulators may react to Lecanemab given the failure of EU approval of Aduhelm. The EU said in its refusal to approve Adu, along with Adu’s side effects, noted this: “The European Medicines Agency noted that although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement had not been established.” See: https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-aduhelm-aducanumab_en.pdf
Anaxex has made it explicitly clear they are ready to move from research to commercialization on Alzheimer's disease
basparks79
What's important are the long-term benefits and blarcamesine is showing to be better than lecanecrud... the extension trial will continue to prove that.
Great catch-comment-thx
G328
He’s going to use the existing data to hammer home the point that Anavex is getting closer and closer to
blu_1,
What do you expect on Thursday? This ride has to end somewhere...IMO.
Georgejji
Less than 24 hours until GREAT NEWS for AVXL
We need and expect a best effort by all.
NEW YORK, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that it will present at the 41st Annual J.P. Morgan Healthcare Conference on Thursday, January 12th 2023, at the Westin St. Francis in San Francisco, CA. Christopher U Missling, PhD, President & Chief Executive Officer will present the Company in a session scheduled 08:15 AM - 08:55 AM (Pacific Time).
A live audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com. An archived edition of the session will be available later that day.
Tom Bishop ...good read...accurate, timely
Anavex (AVXL), is a biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system diseases with very encouraging results so far in Alzheimer’s, Parkinson’s and Rett Syndrome.
The big news for Anavex was the release of the preliminary data from the 508 patient, placebo controlled, double-blind, 48-week, Phase 2b/3 ANAVEX 2-73 (blarcamesine or A2-73) Alzheimer’s trial which tested 3 equal cohorts with placebo, 30 mg or 50 mg oral doses.
First I need to point out two very important things:
1) There was a delay in getting the data from one of the trial sites that resulted in the company only getting the data from the third party statistical analysis company just 1 day before it was on the schedule to present at the CTAD Alzheimer’s conference. This therefore limited what the company could accurately report at that time.
2) Some of the best results from an earlier trial were for the 50 mg. cohort, while the 30 mg barely worked. However, ALL of the analysis presented recently was for the combined 30+50 mg patients as a single cohort, diluting the efficacy results.
Therefore, results yet to come should be even better once the company reports on the 50 mg cohort by itself. The primary endpoints were the reduction in the decline of cognition (ADAS-COG) and activities of daily living (ADCS-ADL) at 48 weeks.
On this the company said, “The Anavex 2-73 (blarcamesine) study met the primary and key secondary endpoints showing statistically significant reduction of clinical decline in global cognitive and functional scales in a clinical study of patients with early Alzheimer’s disease.” (MMSE baseline scores 20-28).
And more to the point: “Treatment with ANAVEX®2-73 statistically significantly reduced cognitive decline, measured with ADAS-Cog, compared to placebo at end of treatment by 45% (p=0.033).”
This is the most significant and directly on point outcome released so far for this trial given this was considerably better than BiogenBIIB +1.9%/Eisai’s 27% slowing of cognitive decline recently reported for lecanemab.
Nonetheless lecanemab's meager result caused those two companies to increase $20 billion in market cap overnight. Most observers believe this Phase 3 result paves the way for likely FDA approval. However, Anavex’s drug beat lecanemab by a wide margin (a 45% slowing vs. 27%) in its Phase2b/3 trial.
But here’s the thing … Biogen’s drug requires IV infusion therapy and periodic MRIs to check for brain swelling and bleeding (two nasty side effects of lecanemab), while A2-73 is a pill and doesn’t require periodic MRI’s, a huge advantage even ignoring that A2-73 worked better.
While the data already released was superior to lecanemab, once the 50 mg alone cohort data comes out the results should be considerably better than for the combined group. And better still for just those 85% carrying the normal SigmaR1 gene as well as for APOE2 and 3 patients. (Still a big target market.) So I think the data so far was encouraging, but the best news is yet to come — and the stock remains a favorite for 2023.
Very positive : https://www.forbes.com/sites/moneyshow/2023/01/09/6-favorite-biotech-bets-for-2023/?sh=2e7d28e28ae5
WOW...the pot is starting to steam a little. Soon to be boiling hot....
What happens next?
Do we get a (maybe-probably- someday) package or do we hit a grand slam?
Obviously there is a lot more at stake here than just one more CNS diseases trial. This is a systems event.
IMO, this is for all the marbles played for the last 30+ years by the combined systems. (Insurance co.'s, medical device product producers of MRI and every type of combination techs, the whole memory care industry, the clinics for infusions, home care industries, WS, etc.. The entire line of Amyloid (read uncertainty )driven healthcare clinics and practices...the list goes on.
Future direction for BP investment plans could all be decided by simple-direct AVXL trial results. Are we about to disambiguate the stack? There are a lot of stacked interest in the status quo crowd who kinda like things as they are right now. Lots of money on the table. IMO, strong trial results from AVXL will point to WS uncertainty in certain investment areas .
AVXL, needs a solid walk-off victory kind of session. In fact, maybe WS has not seen such an event and all the brilliant-money people have to rethink some plans. We'll see. Those folks who stir up and thrive on uncertainty to make a living must hate this kind of drama.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s000lbl.pdf
Apparently the FDA without an advisory group of physicians did NOT consider all of the trials and all of the data BEFORE making their decision.
crescent? Any insights (biostat source) on AVXL-OLE PDD results? TIA.
Very shortly an independent biostat firm will report out how many of the 200 patients in SAVA's OLE trial demonstrated some cognitive improvement (not just an improvement in decline in ADAS-COG scores after a year's Simufilam dosing.
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?