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could...Lymphoma is a common cancer...It is being treated with toxic doses of chemotherapy, accompanied by high doses of steroids, to allow to patients to tolerate the inflammation brought on by the toxic chemo Rx...A version of EPA, which favors the entry of EPA into lymphoma cancer cells , could lower the amounts of dangerous steroids, necessary to be used used in combating the chemo inflammation, and make the treatment more tolerable and less risky.
An example of how devastating a diagnosis of AD can be was illustrated by a recent case of fraudulent diagnosis of AD in TOLEDO, Ohio
-- QUOTE..."A former director of an Ohio memory-loss clinic accused by dozens of patients of falsely diagnosing them with Alzheimer’s disease has been sentenced on federal fraud charges, along with her physician husband.
Sherry-Ann Jenkins received nearly six years in prison on Tuesday, while Oliver Jenkins(MD) got a 41-month sentence. The couple was convicted in March on conspiracy, mail fraud, wire fraud and health-care fraud charges after being indicted in May 2020.
The U.S. Justice Department has said Sherry-Ann Jenkins was not trained or licensed to provide any medical care but presented herself as a doctor and billed patients for unneeded treatments....The patients said they spent months undergoing treatment while planning out their final years, thinking they would die soon. Some quit their jobs or took one last special trip. One killed himself; others said they considered suicide."
If Vascepa is shown by the Brave study to provide even a modest amount of help in delaying the onset of AD or ameliorating it,(in addition to its positive effect on CVD and other diseases) the drug would be very well received by the world.
Alzheimers is a terrible disease, which , not infrequently, leads to suicide,....Even a mildly positive study would instill some hope in those, who are afflicted.
Gordon...QUOTE FROM HOLT..."China sales for HTG will start late this year"....That would be as much a game changer as R-IT was. The massive China population which could potentially benefit from EPA, would change EVERYTHING regarding inventory, wholesale and retail prices, distribution....AND the value of Amarin.
Its only a few months away...Lets hope that Holt has gotten it right about his most important announcement at his first conference as Amarin CEO this A.M.
-"plans and partner" in place for an authorized generic at any time
-"launch by the end of the year in CHINA"...IMO, this should hasten the decision to have an authorized generic in the U.S.
Holt seems to know his stuff and spouts less BS than previous CEOs...but I wish he wouldn't let the volume of his voice trail off often at the end of his sentences.
Bob...This is Holt's maiden conference with Amarin...I doubt that he would have scheduled it...if he didn't have something of value to impart to us shareholders.
Tal...thank you for your informative post...QUOTE..." kindly find below Background Notes and four (4) questions from which you might wish to pick."
I would pick question 4 from among all these good questions(especially about the authorized generic)... As JT was wont to say..."Vascepa is not a price play... but a volume play"....Sooner or later, Vascepa will be used worldwide...I would have it be sooner.
Institutions don’t care to be linked to a “fish oil company”
Tats...If you made a bet(without odds) that...during the next the next 12 month period... one of two outcomes would occur...
1. Amarin goes bankrupt during this period
2. Amarin achieves serial positive cash flows during this period
Which bet would you take?....And if you choose the second bet, would you consider the stock presently undervalued?
Pdude...Thanks for the article...My personal observations from myself and my wife have lead me to believe that Vascepa has mood elevation as one of its pleiotopic effects...I would like to see studies on that particular function of Vascepa.
Capt...Medicaid patients get their RX's filled at no charge to them...Medicaid patients usually see generalists rather than specialists...So Amarin has to educate generalists about Vascepa....i.e...about Vascepa's efficacy in reducing CVD, but also about its beneficial anti-inflammatory effects in many other diseases.
KIWI...Thanks for this thought provoking article...QUOTE...."They say abnormal amyloid starts to build up in the spaces between neurons, leading to brain INFLAMMATION, which the neurons do not like. This starts to change their internal chemistry."
I suggest the following sequence occurs in Alzheimers...
1. inflammation in brain
2. changes in the internal chemistry of neurons
3. death of neurons
4. deposition of amyloid in brain
5. more inflammation
If we can find a way to reduce the inflammation in the brain, perhaps we can favorably make changes to this vicious cycle.
i. e. ...INFLAMMATION IN THE BRAIN SETS UP A VICIOUS CYCLE!
A positive result from the Brave study would reinforce the evidence that EPA has anti-inflammatory action on Alzheimers disease...This would prod medical science to investigate other conditions, which also are in need of help from an anti-inflammatory drug.
Lymphoma is presently being treated with very toxic anti-cancer chemicals, which, in addition to their beneficial properties, cause severe inflammatory side effects...The anti-cancer chemicals are given along side huge doses of steroids to reduce their inflammatory side effects, especially over a long duration...However, the steroids are ALSO well to known to have serious side effects...EPA, which is a safe and effective anti-inflammatory drug could be used to to reduce the amount of steroids, which need to be given to these sick patients, while preserving the goals of the anti-cancer chemicals....i.e. the steroids could be tapered off while the safe EPA is continued.
JR..."But look at it this way - he is giving everyone ample opportunity to buy low!"
Those of us, who were buying in the double digits can now no longer afford the opportunity to buy low.
Any price lower than the double digits will be vigorously opposed.
Also a reverse split would be an anathema...Even PWO did not propose that miseable scenario in his disastrous stewardship of Amarin...I would rather see Amarin delisted from the the Nasdaq.
Tats...QUOTE..."Denner tells you himself he's playing both sides of this."...I disagree...Denner is only explaining that he has the right to do this...IF he pleases...This is a far cry from saying that he is currently playing both sides.
You are obviously intelligent...but what reason do you have for being so down on Amarin and anyone affiliated with it? ...Have you lost a lot of money on the long side?...Are you now on the short side?
After billions of dollars have been spent in failed trials, aiming to demonstrate that Amyloid is the cause of AD(rather than an effect)...even a modest success in the Brave study, which uses a safe, relatively inexpensive, anti-inflammatory, pure EPA drug, which is administered orally... would have a stunning effect on the medical world and on W.S.
CBB...Your conclusion about the significance of this additional investment in AMARIN by Dr. Denner parallels mine...With this purchase, Denner has made a statement that that he believes in Amarin and is willing to put his reputation on the line.
Those posters, who are constantly and gratuitously insulting Denner...and submit weird theories, without a grain evidence to back them up, and which attribute evil motives to every action he takes, are definitely NOT allies of Amarin or of its shareholders.
I respect these posters when they give information or reasoned opinions about Amarin...not when they give unfounded abuse.
Dr Denner believes that Amarin is way underpriced...and this is his way of stating it.
I was relatively young when I first bought Amarin shares(or ,at least, I felt that way,, but since that time, I've gotten older in a hurry.
jas...I erred in referring to him as Nessen rather than Nissen...At least I apologized...something which is not in Nissen's playbook, when he errs.
Since Nissen became famous by correctly accessing the dangers of Vioxx, which was taken off the market due to causing serious CVD problems... and, which episode persuaded Merck to pay out almost $5 billion to settle lawsuits, Nissen has been trying mightily to find another drug to criticize in order to retain his new found fame...He has been relatively unsuccessful of late...so he decided to try his luck to take down Vascepa...Unfortunately for Nissen, but fortunately for patients, that effort has mostly backfired, but not before he was able to inflict some serious harm to Vascepa and to patients.
Orbapu...Even though the article was intended to be a hit job by Ridker, it was actually supportive of the fact that whatever small effects the MO placebo may have played in the R-IT study...they did NOT negate the excellent results of the study...This conclusion, which is the antithesis of Nessen's previous hypotheses, meant that Nessen's ego would not permit his name to be on the list of the authors of the study...
i.e....list of authors of the Circulation article
Paul M Ridker,
Nader Rifai,
Jean MacFadyen,
Robert J. Glynn,
Lixia Jiao,
Ph. Gabriel Steg,
Michael Miller,
Eliot A. Brinton,
Terry A. Jacobson,
Jean-Claude Tardif,
Christie M. Ballantyne,
R. Preston Mason and
Deepak L. Bhatt
Originally published28 Jun 2022http
Nissen is probably waiting for the next more damning hit job on Vascepa that appears, to affix his name to it.
Nessen did not like the science that showed that the DHA in Omacor blunted the role of the EPA in reducing CVD...and embarrassed him because of his mistaken advice to AZ to first pay a high price to buy Omacor and then to spend even more to prove that it works...He will forever blame Amarin and Vascepa for his failure...no matter what the evidence has already shown or will shoe in the future.
Nsleven...IMO, The most instructive parts of the article in the CIRCULATION journal were "What net clinical effect the current data, if taken in combination, might have had on outcomes in REDUCE-IT is difficult to estimate."
HOWEVER...
"Regulatory agencies evaluating REDUCE-IT estimated that approximately 3% of the net clinical benefit observed with icosapent ethyl might have been a consequence of adverse biomarker effects on LDL cholesterol and hsCRP attributable to mineral oil....In the context of an overall 25% relative risk reduction in first events and a 30% reduction in total ischemic events observed, a potential bias of this magnitude, even if doubled in size, would be unlikely to fully attenuate the overall benefit of icosapent ethyl observed."....
QED...Vascepa is valuable in lowering the incidence of CVD!
mivan...QUOTE..."The Italian agency has published these updates on vazkepa. It seems it did not fulfill the standard of innovation requested.
The most disappointing thing to me is that the quality of Reduce-it they judged as 'Low' "
Is it really the quality of the R-IT study they regard as low?...or Is it the product itself...?unsafe...?ineffective...?too pricey?
How can Amarin improve the quality?...My guess is that the.. the "quality is low" for Vaskepa...actually means that, in their estimation, the price is high.
Apparently Spain, England, Denmark, Sweden,Israel etc. did Not believe the quality was low.
"In 1928, a chance event in Alexander Fleming's London laboratory changed the course of medicine. However, the purification and first clinical use of penicillin would take more than a decade. Unprecedented United States/Great Britain cooperation to produce penicillin was incredibly successful by 1943."
In the late 1930's, sulpha drugs were still the most commonly used drugs for infections...I myself was, in 1939, treated with a sulfa drug for a foot infection even though penicillin might have been available then...It took years for even a remarkable drug like penicillin to be commonly used....IMO Vascepa will be commonly used in the future....perhaps not like penicillin, but possibly like statins.
jas...Penicillin came from a mold belonging to the Penicillium genus...It was successful because it was effective in treating bacterial infections...Patients and Docs did not care that it came from Penicillium mold.
IMHO, How EPA is produced is less important to me than how it helps CVD...The evidence that Vascepa reduces CVD with almost no side effects is what is important to me and, I think, to most people....i.e. as long as the process to produce Vascepa is as safe as the product is.
I am thinking of Vascepa from the point of view of a consumer, not of a chemist.
mrmain..Spain and Europe are now slowly getting to understand the value of Vascepa...and they will buy Vascepa in quantity when the price is right...The greater volumes of sales will lead to greater profits and translate into increases in price of Amarin stock.
ORB...QUOTE "Associating Vascepa with fish oil just because fish oil happens to be the source of EPA, used in its manufacturing processes is misleading".
YOUR STATEMENT has a grain of truth to it...HOWEVER...Most people do not have the background in chemistry needed in order to understand anything about the esterification process that fish oil is subjected to, to convert it into purified EPA by separating the EPA from the other constituents of the fish oil(especially the DHA)....
A few other considerations come to mind...
-Vascepa has always, from its beginnings , been labeled as a fish oil...and it probably always will be.
-most people do have some understanding of what the words, highly purified, might imply.
-Why not embrace Vascepa as a highly purified fish oil since it will forever be linked with fish oil anyway..and fish oil is not really a bad thing(as witnessed by its historic huge sales globally).
JR and Jas...This current huge market for fish oil presents a challenge for Amarin...but even more of an opportunity ...
-Amarin should not run away from Vascepa being a healthy extract from fish oil...
-Amarin should begin emphasizing the fact that Vascepa, as a highly purified extract of fish oil, definitely HAS been proven to reduce CVD...while fish HAS been proven NOT to reduce CVD
-So Amarin needs to ask people why they are continuing to waste their money on fish oil...People should use Vascepa INSTEAD OF FISH OIL!
The market is already established(as it has been in the past for aspirin and statins)... All Amarin now needs is a new and enlightened approach to make it work!
Hundreds of millions of dollars are spent each year, in vain, by patients seeking to reduce their risks of CVD by taking EPA-DHA drugs, such as Lovaza, Omacor, and various fish oils ...Yet the important studies that prove that DHA blunts the action of EPA in reducing these risks... remain unpublished for years...Why??
The FDA is a political body as are the Courts...The judges in the Courts and the supervisors and commissioners in the FDA are political appointees...The prevailing political winds are in favor of the generics...and the Congress, the Courts, and the FDA are aware of this....This leads to the present situation in which there is obvious corruption of the HW law, but no one wants to correct it.
Denner is now easily able to change the "no standing" issue, which was then due to PWO's intransigence... It was the cause of Marjac and Amarin being denied justice in Amarin's "fraud on the court" case...The "no standing"issue,being easily rectified by Denner, could allow Amarin and Marjac, possibly with additional help from other excellent lawyers, to renew litigation of Amarin's case on a contingency basis.
The ubiquitous, nasty corruption of the H-W law by skinny labels, which is presently being tolerated, is HUGE...With very sharp and learned lawyers and with just courts and juries, the damage awards due to Amarin should also be HUGE!
Amarin...If you still have any residual belief in justice after what happened in the Du case, DON'T make any deal with DR in their Sherman anti-trust case...and DO sue Dr. Reddy for their infringement of the Amarin CVD patent!
Correction..."the difference in an increase in the percentage of AF between the two arms is a misleadingly large 72% increase in the EPA arm."...
Error...The difference would be 28%
Jas...An example of Dr. Nessen's biased analysis of the R-IT study is manifested in how he chooses to report the incidence of the atrial fibrillation risk in the EPA arm vs. the incidence of the atrial fibrillation risk in the placebo arm of the study....
The incidence of AF in the placebo arm being 3.9%
The incidence of AF in the EPA arm being 5.4%
There are two ways to report this increase in incidence of AF in the EPA arm over the placebo arm...
First. way---- compare an increase of 5.4% in the number of patients with the AF side effect side effect in the EPA arm as opposed to the to the 3.9% increase in the number of patients in the placebo arm...this difference between the two arms is then reported as relatively small 1.45% increase in the EPA arm.
Second. way----compare the 3.9% increase in the patients in the placebo arm side with the 5.4% side effects in patients with patients in the EPA arm...and to then report the difference as an increase in the percentage of AF between the two arms as a misleadingly large 72% increase in the EPA arm.
This way of reporting by Dr. Nessen leaves the false impression that Vascepa(EPA) has severe side effects, which it DOES NOT!
I blame Dr. Nissen...He knew better, and had no reason to spout out all the nonsense that he did about the MO placebo in the R-IT study being the reason for the success of Amarin's R-IT study....
Except that Nissen had previously advised to AZ to buy Omacor(which contained DHA as well as EPA), for an large amount of cash, as a potential competitor to Vascepa...and then Nissen convinced AZ to do very expensive studies on Omacor...
When AZ ultimately turned out to be an expensive and an embarrassing failure, it did great harm to Nissen's reputation...
After this very embarrassing episode, Nissen blamed Amarin because it had done a very successful R-IT study on Vascepa....This episode has seriously hurt Nissen's reputation as a medical wizard, inducing him to continuously discredit Vascepa by implying that Vascepa would have also failed, as did Omacor, except for the R-IT MO placebo making the R-It study make Vascepa look superior to Omacor on reducing CVD...
Nessen's argument concerning the importance of the negative effects from the small quantities of MO used in the R-IT study placebo study, has been conclusively proven to be false.
Tal... "A party cannot be compelled to arbitrate a dispute unless it has agreed to arbitrate it."
Since DR is the plaintiff here, I assume that DR initiated the arbitration request...If not for judge Du's adverse decision on the Marine patent in Marcn, 2020... which then allowed DR and others to infringe on Amarin's CVD patent, Amarin would NOT have had enough API to satisfy their current needs...IMO this suit by DR should be followed by a counter suit for infringement, with DR as the defendant and Amarin as the plaintiff, .
I would have preferred it... if Amarin had not agreed to the mediation and, instead, gone directly to a counter suit.