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The causes are known
Check Anavex studies and chromatin structures
That was easy good return Thank you. ?????
Thanks for posting...
As Eli Lilly states in its AZD page..The causes and cures of AZD are not known at the present time..I think this is an accurate statement..I think the FDA approval of the Biogen drug is a farce...I don't wish to pee in the punchbowl but the idea of a drug with an estimated annual cost per patient of $56K and no proven efficacy should be investigated...
AZD is a degenerative disease...a disease of aging..most of these disorders are related to inflammation..AZD has ties to CVD which is another manifestation of chronic inflammation..As we know there is a hereditary overlap in all these diseases in terms of their age of onset..Which is also effected by lifestyle factors,,,such as diet, stress and enviromental toxins..All factors which effect longevity...Not everyone has a basal body temperature of 98.6* F...If your resting temp is 99.6* F Then like a roast in the oven the higher the temperature the faster the roast cooks. Same thing with pulse rates...In mammals there is a law that says the faster the pulse rate the shorter the lifespan...and there are no exceptions..Just check your dog's pulse rate..
In my own case. I just turned 80...And I can tell my memory is nowhere near as good at it use to be..I go by the "Jeopardy" test..At age fifty there would be only two or three contestants a year on Jeopardy that could beat beat me...Know almost everyone who wins a contest easily trounces me..It's not that I can not dredge up the answers over a period of time in a lot of cases...It's just there is a long delay period before the answer.
Want to avoid AZD...I don't think Biogens $56 drug is going to help you and its not going to help the cost of medicine in the USA. Watch your lifestyle don't smoke and cut down on your food intake and fast acting carbs. Take Vascepa..(I don't own any shares at present..and watch Jeopardy. Exercise for the mind..
":>) JL
Third member of FDA expert committee resigns over controversial Alzheimer’s therapy decision
By Andrew Joseph June 10, 2021
A third member of a Food and Drug Administration expert panel has resigned over the agency’s contentious approval of an Alzheimer’s therapy this week, a sign of a growing backlash over the decision.
In a letter to acting FDA Commissioner Janet Woodcock on Thursday, Aaron Kesselheim, who had served on the FDA’s advisory committee for nervous system therapies since 2015, wrote that the approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
“It is clear to me that FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions,” wrote Kesselheim, the director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law. He also cited the FDA’s decision to approve Sarepta Therapeutics’ eteplirsen for Duchenne muscular dystrophy in 2016 over the recommendation of the advisory committee in his decision to quit.
Kesselheim’s resignation follows those of neurologist David Knopman of the Mayo Clinic and neurologist Joel Perlmutter of Washington University in St. Louis. Perlmutter wrote in an email to STAT Tuesday his decision to quit the panel was “due to this ruling by the FDA without further discussion with our advisory committee.”
Knopman, whose resignation was first reported Wednesday by Business Insider, was recused from the aducanumab panel because he had been a trial investigator.
But during the panel’s November hearing on the therapy, 10 of the 11 members voted that there was not enough evidence to show Aduhelm, also known as aducanumab, could slow cognitive decline, recommending against its approval. The 11th voted “uncertain.”
Related: Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer’s drug
On Monday, however, the FDA granted Aduhelm an accelerated approval based on the drug’s ability to clear toxic protein plaques in patients’ brains — a regulatory route that FDA officials told the advisory committee in November was not being considered. In explaining the approval, the FDA acknowledged Aduhelm had not demonstrated a clear clinical benefit in terms of slowing disease progression, but argued that by removing the plaques, Aduhelm “is reasonably likely to predict a clinical benefit to patients.”
The FDA also told the chair of the panel Monday that “further discussions” within the agency after the panel’s hearing led to the decision to use the accelerated approval pathway.
The FDA does not have to follow the recommendations of its advisory committees, and researchers have found that it has gone against the votes about 1 in 5 times in recent years. But generally, such overrulings occur when the votes are much closer.
I am in for the WEN thank you. God bless you.
The Structure of Chromatin
I’d rather take a drug that doesn’t add worry to the situation
Hi, JL. I do agree that the FDA’s accelerated approval of Aduhelm based on the premise that clearing amyloid is “reasonably likely” to predict a clinical benefit was a serious overstep.
It’s now going to be much harder to conduct illuminating clinical trials of other AD drug candidates. Few patients will want to enroll in a trial with a placebo arm, and a head-to-head non-inferiority study of a new agent versus Aduhelm wouldn’t really demonstrate anything even if the trial met its endpoints.
Roy....
You know better than anyone that the road to therapeutic Nirvana is paved with land mines...The role of Beta amyloid in the pathogeneses of Alzheimer's Dementia has never been elucidated, and remains one of the great mysteries of clinical medicine..
There exists oblique evidence that suggest that dementia is not created by focal disruption...Multiple Sclerosis is an auto immune disease that results in focal areas of neural loss both above and below the Foramen Magnum...Although MS patients can develop cognitive issues in most cases this is not the impressive aspect of the condition like dementia is in AZ..
If Beta A was the prime cause it would have to function by creating focal disruptions (like MS does)..Most AZ cases begin with personality changes..
Interestingly...Jealousy is a frequent prodrome..
Finally AZ is a disease of aging...And those of you are are veterans of the Vascepa wars know and understand the ravages of aging are principally the effects of inflammation. I would bet AZ is no exception to the rule...Why should it be...
In would like to see a a race between Vascepa and the BIIB drug and would bet heavy money on Vascepa...
Hope all is well
":>)JL
I guess if it works for Joe, the FDA said it works for everyone.
I wonder if living in a basement is a requirement.
No matter what BIIB! Go for it and produce these Amyloid Busters.
And do not forgot to cut down on the fried food!
Alzheimer!!!! what a great Money Maker!
You got a piece of history there.
Hope it is kept as a lucky decision but you will never know down the road. Some drugs get found with serious side effects after a couple of years and Aducanumab is known with serious side effects already.
Wish I got in this in the morning! Will be watching it tomorrow, should be a fantastic day for swing trading.
BIIB made a lucky decision 14 years ago:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=24682934
That’s where Aduhelm came from.
* * $BIIB Video Chart 06-07-2021 * *
Link to Video - click here to watch the technical chart video
BIIB having a monster session
Talk about a short squeese
the shorts just took another big one up there ass
Approved with a note from FDA!
The note puts a quash on any
Massive profit they were expecting!
Should open with euphoria pump
And fade!
That's my take.
Give it a week.
BIIB gets FDA approval...stock halted.
You are surely correct and yet things are so corrupt I think it could surely go that way. I was getting emails from the head of ALZ ORG telling everyone to work for it's approval. Sent him one asking how much they were paying him and how he slept at night
It can’t be worse than Jan 6th!!!
? update me. I haven't been following BIIB for a cool minute
June 7th will be a real national embarrassment if it goes the distance with aducamab
I just read the transcript of the earnings conference, and it seems earning projections factor in approval of a new alzheimers drug still being evaluated by the FDA, which has had a negative vote in the past. Can anyone tell me why they are so confident? None of the questions asked seem to address that directly, although a couple mentioned the new drug adu.
add another rope a dope to biogens belt notches..
greatest scam ever..just terrible..
hey Tatonka..yeah it's the same damn cliff..
there is ZERO doubt that a great therapeutic is near by..
Anavex, Annovis, et al..
but this tub of deceit wont get out of the way for REAL HOPE..
DISGUSTING..I calm myself withknowing that someday this drug MAY be an AJUNCTIVE to a real therapy..but my guess is ..
Anavex and ANNOVIS will NEVER need aduscamandrob....
I would take a chance on an Alzheimer stock with a extreme potential rather than a gamble on Biogen with no FDA approval jet.
Just my view of course.
Take a look at CBBT your competitor priced at .12 usd
Totally agree, saw $CBBT making huge gains over the last three months
Cerebain Biotech is priced at 0.12.
If they succeed the Alzheimer approval.
Better priced than Biogen....
Who will winn the Alzheimer medicin....
Imo cbbt a once in a lifetime chance...
Anavex now in trials for PDD, Rett, Alz with patent Approval now for Cerebal palsy, MS, Autism, Angelman's is going to rock the CNS world and leave Biogen with their pig with lipstick Aducamab. Better act soon cause licenses will go quickly once Rett results data comes out by Dec 15th and additional data on PDD.
and you dont think that is priced in? $300+ to $240 kerplunk?
I dont know if you are aware the great Alzheimer lie has several class actions on the table. Not good when BPs lie.
Chart says differently and will re-enter if there is any sell off to $220s or lower
http://schrts.co/rcwpuGeC
Weirdly this stock goes up and down almost the exact same amount each time they release through a PR that I heir Alzheimer’s drug has a chance to be efficacious. Cant take these guys serious and cant laugh about it either now that its the fourth time!
AVXL is ripe for the picking, be it institutional, small investor, partnership or buyout.
Time for a new ethical CEO. Perhaps the shareholder could buy AVXL before Eisai buys them out.
Unfortunately, this thumb’s down vote is not binding. The FDA could still approve aducanumab:
“The nonbinding vote by an advisory panel for the Food and Drug Administration does not mean the agency won’t approve the drug, aducanumab, made by Biogen. But it signals that many experts in the field are not convinced of its effectiveness, another major setback in the long journey to find a treatment for Alzheimer’s that works.”
https://www.nytimes.com/2020/11/06/health/aducanumab-alzheimers-drug-fda-panel.html
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http://finance.yahoo.com/q/ks?s=BIIB
Biogen Idec Inc., a biotechnology company, develops, manufactures, and commercializes novel therapeutics in the areas of neurology, oncology, immunology, cardiopulmonary, and hemophilia in the United States and internationally. The company?s marketed products include AVONEX for the treatment of relapsing multiple sclerosis (MS); RITUXAN for treating relapsed or refractory, low-grade or follicular, CD20-positive, and B-cell Non-Hodgkin?s Lymphoma (NHL); TYSABRI to treat relapsing MS; and FUMADERM for the treatment of severe psoriasis. Its products under development consist of BG-12, a Phase III clinical trial product for the treatment of MS; Humanized Anti-CD20 MAb, a Phase III clinical trial product for the treatment of rheumatoid arthritis and lupus nephritis; Lixivaptan, a Phase III clinical drug for the treatment of Hyponatremia; Daclizumab, a Phase II monoclonal antibody that is being tested in relapsing MS; and Fampridine, an oral compound as a treatment to improve walking ability in people with MS. The company?s products under preclinical stage comprise BIIB014, Ocrelizumab, Neublastin, LINGO, and BART for neurology; Hsp90 Inhibitor, GA101, Anti-IGF-1R, Volociximab, Anti-CRIPTO, RAF Inhibitor, and Anti-Fn14 for oncology; Anti-TWEAK, Anti-CD40L Fab, and Anti-FcRn for immunology; and Long-acting rFactor VIII for hemophilia. It has collaboration agreements with Neurimmune SubOne AG; Cardiokine Biopharma LLC; UCB, S.A.; Swedish Orphan Biovitrum AB; Facet Biotech Corporation; Vernalis plc; and Schering AG. The company was founded in 1985 and is based in Cambridge, Massachusetts.
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