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KM says that Amarin is working on two versions of a statin-Vascepa combo...
This might be a blister pack with a 20 mgm statin and 4 grams of Vascepa plus a blister pack with a 40 mgm statin and 4 grams of Vascepa....or some other combinations
Amarin could profit from the patent exclusivity of the fixed dose product and absorb the cost of the statin...making the price to the patient about equal to that of the Vascepa alone.
Amarin is presently developing a prototype and should be in manufacturing mode soon.
Since both the statin plus Vascepa have already been approved by the FDA, I doubt that further trials will be required.
Capt...Interesting dilemma...As we all know, the market reacts to good news with greed and to bad news with fear...In both instance, the market usually over-reacts and then corrects.
If the market has over-reacted to good news, sell some shares and then buy back at a lower price
If the market has over-reacted to bad news, buy some shares and sell at a higher price
In order to make this work, you have to know a lot about your stock so you can fully interpret the importance of the good news and the bad news. and their influence on the stocks' near and long term fortunes.
This becomes a problem when you own more stocks than you can
adequately keep up with.
In the case of Amarin's better Q2 2022 than Q1,2022, I believe it presages good things to com...and i would not sell unless there was a gross over-reaction to the good news.
sts...Thanks for that analysis, but I respectfully disagree with this aspect...QUOTE...
"My predictions are very similar to HDG on Q2 results. Basically improvement from 2022 Q1 but dismal miss from 2021 Q2....I expect a pull back in share price"
2022 Q1 results stimulated the fear of an Amarin bankruptcy by the market...Q2 results will show that fear to be unfounded...and the stock will tick up due better results in Q2 than in Q1, stimulating the expectation of still better results during the year and beyond.
HDG...I agree that, barring an unlikely turn of events...due to exclusivity being lost...success with Vascepa is now dependent on volume.
Success for Amarin means additional indications for Vascepa through investments in patient studies, approvals by regulatory agencies and direct to consumer marketing....These projects require financial assets, which Amarin does not presently have...and is unlikely to have in the near future..Thus the need for Amarin to be sold to a BP.
If not for Amarin's failure to defend its high triglyceride patents, Amarin might have been able to do it alone with its CVD patents in tact, but...due to massive 'skinny label' infringement, those prospects have now evaporated.
KM assumed the job as CEO of a sinking ship one year ago and has done a good job of righting it...This should give him increased leverage with the board...IMO the future of Amarin hinges on performing well enough to attract a good offer from a BP...I hope KM cooperates with Denner in this endeavor rather than following Ekman who showed his lack of faith in Amarin by selling all of Sofinnova's shares of Amarin, while refusing to support Marjac's appeal(lest he antagonize his friends at Covington}, and then had the audacity to still stay on the job as COB instead of resigning immediately.
Kiwi...Why not treat patients who are recovering from serious Covid with long term Vascepa?...At the very least, post Covid syndromes deserve to have studies done in order to see whether Vascepa can mitigate the after effects of Covid.
Sleven...This another reason for a BP to get involved with Vascepa...i.e. to conduct studies leading to more indications for Vascepa...These would include colon cancer, ulcerative colitis, irritable bowel syndrome, nephritis, dry eyes, post surgical trauma(e.g. JL used to report his superior results by using Vascepa in face lifts in the post-operative period), etc.
dogn...The solution is simple...Remove the printing from the capsule...Put a picture of the capsule on the bottle of capsules.
Study...QUOTE..." a study has never been funded looking at the difference of CVD differences between gV and V users."
The FDA has recently changed its mind after demanding an event study from Amarin for CVD ....It now seems willing to approve drugs on lab studies...A lab study showing that the EPA in gV was oxidized...together with an understanding that oxidized EPA is inferior to unoxidized EPA should be sufficient to determine the inferiority of gV.
RMB...QUOTE..."for Dr. Bhatt to say that these were not done since no one funded them is discouraging"
Perhaps Dr. Mason was funding this study of gV oxidization of EPA by himself, expecting more funds to come from Amarin...which never arrived.
The bad odor from gV is 'diSTINKive'...Vascepa is 97% pure EPA...It would make sense that the bad odor of gV comes from oxidized EPA... due to the inferior capsulation the EPA
Oxidized EPA is less effective in reducing CVD than unoxidized EPA...Even though the FDA may not care, Amarin should care...along with Docs and their patients.
It is reprehensible for Amarin not to have immediately funded these studies!
Craig Granowitz was the chief medical officer of Amarin from 2015 through August of 2021...Why didn't he immediately institute studies of the bioequivalency of the generic knock offs of Vascepa ASAP as they began hitting the market post the Du decision on March 2020?
Was that error of omission due to JT or Ekman or Granowitz or all three?... Management remained in shock and unconscious at the wheel...A BP would not have made that mistake.
Canes..."If they(Q2 earnings)are yet again abysmal with a significant cash drain my suspicion is he won’t wait another quarter."
I believe Denner will act even if Q2 earninga are good...and predictive of future good ER's
IMO Denner's main goal is to sell Amarin within two years...A good Q2 ER will presage further good quarterly earnings reports and will help him to sell Amarin to a BP at a fair price.
I intend to use the proceeds of such a sale to buy shares in the BP that acquires Amarin, since I believe that Vascepa will be transformed into a blockbuster drug when promoted by a BP.
RMB...QUOTE..."the earlier misfolding of amyloid-beta causes the later plaque deposition. However, it is still controversially discussed whether this misfolding is the cause of Alzheimer’s disease or if it’s just an accompanying factor.”
Studies have shown that meds, which have the effect of removing amyloid plaque from the brain, have FAILED to improve AD.
The 'misfolding'(leading to plaque formation) is a symptom of AD, rather than the cause...This why, IMHO, the anti-inflammatory effects of Vascepa on the brain will be proven by the BRAVE study, when completed in January 2023...to mitigate AD, if used in the early stages of the disease...i.e. BEFORE significant deposits of plaque occur.
Nsleven...You and I agree that the intent to infringe to infringe by skinny labels is obvious...But how do you prove intent in a court of law?...This is usually more difficult without Amarin's overwhelming evidence in the HN case.
In the Amarin case against Hikma, judge Hall accepted evidence that Hikma had discussed sales goals for gV at a public meeting, that would be unattainable without infringing on Amarin's CVD patents, but judge Andrews was still unconvinced.
Nsleven...Amarin has a very good case against Healthnet. HN will do what's in their own best interests and will settle with Amarin...This will send a message to other health insurance companies to avoid requesting PA's for Vascepa.
Unfortunately this removal of the burden on Docs to write PA's for Vascepa will will help sales of Vascepa by infringing generic companies but it will also help sales of branded Vascepa.
As for Congress fixing HW, I wouldn't hold my breath.
CB QUOTE..."If HN were to change their policy on the PA wouldn't that be like an admission of guilt?"
I was thinking the same thing...and this might be a reason why HN is continuing to infringe with their requests for a PA, while potentially negotiating a settlement with Amarin...Does anyone know whether any other insurance companies are also requiring a PA before they agree to pay for a Vascepa Rx?...If so, they are infringing on the majority of Rx's for Vascepa and Amarin should sue them as well.
If you have auto insurance and your engine dies...and is replaced by your insurance company with an engine that they have purchased more cheaply, but which is infringing on a patent, is not the insurance company guilty of infringing?
Pdude...Health net is in the business of charging fees to assist the patient in obtaining a product with less cost out of pocket...They are, in fact, subsidizing the product in return for the fees the patient is paying...If the product is infringing on a patent , they are guilty of infringement...If Healthnet wishes to try their luck by having extended court cases, the damages will be even more onerous to them when they lose...Insurance companies are usually not in the business of gambling...Amarin gambled with the courts and lost billions by doing so.
QUOTE..."Should HealthNet not be allowed to offer gV if they know it is for CVD? It’s not HealthNet’s job to enforce the patents. If gV costs them less than V why do they have to charge more for gV just so they don’t induce their client to violate a patent that their client has no idea even exists?"
Should HealthNet not be allowed to offer gV if they know it is for CVD? It’s not HealthNet’s job to enforce the patents. If gV costs them less than V why do they have to charge more for gV just so they don’t induce their client to violate a patent that their client has no idea even exists?
Should HealthNet not be allowed to offer gV if they know it is for CVD? It’s not HealthNet’s job to enforce the patents. If gV costs them less than V why do they have to charge more for gV just so they don’t induce their client to violate a patent that their client has no idea even exists?
Nsleven...You are correct....Healthnet tripped over themselves with greed...
Healthnet figured they could lower their costs by putting an impediment in place for Docs to prescibe Vascepa for their patients by demanding a prior authorization,which they know many Docs are hesitant or unwilling to spend their time on.
Healthnet also correctly understood that the vast majority of scripts being written for Vascepa were for treating CVD rather than high triglycerides. They reasoned they could save money by reducing the number of scripts they had to pay for by demanding these prior authorizations.
This plan backfired when Docs wrote prior authorizations for the patients' CVD and Healthnet filled them with generic Vascepa... in clear infringement of Amarin's CVD patents.
Insurance companies all know that they are infringing on Amarin's CVD patents when they fill the prescriptions for Vascepa with the generic version, but they do it anyway to save money for themselves by dispensing the generic version, which they pay less for.
This time, Healthnet let their greed get the best of them.
CBB...QUOTE..."Who watches the "journalists" that make their own allegations? ...(They can claim freedom of speech as their defense.)"
I agree... but if these"journalists" are also shorting the stocks of their target companies...in order to profit from their attack articles, they are criminally violating SEC rules.
I would like to see an investigation opened to see whether that is happening in the case of the destructive campaign against Amarin...centered around the attempts to discredit the R-IT study's successful findings...via assertions of bogus MO placebo effects on the study results.
raf...I agree..In most trials, there are benefits and risks to patients who are in either the active arm or the placebo arm...This is why it is important for trials to go to completion, without announcing preliminary results....unless they run into unanticipated excellent or bad results.
This situation is further complicated when scientific forums put a lock on the prior publication of studies before they can be released exclusively at their own meetings...even after such studies have been completed and analyzed...a practice which IMO borders on being unethical.
At least the top line results should be made available ASAP.
Nsleven...75 years ago, I was working part time as a soda jerk(at the age of 13) and as a seller of over the counter meds at a local corner pharmacy...I noticed, at that time, that a myriad of meds had the label, McKessen on them...They changed their name from McKessen and Robbins after management faced a criminal scandal, in which one of the executives committed suicide...I always thought of them as a distributor and not a manufacturer or researcher of drugs.
IMO the involvement of McKessen in distributing Vascepa is neither a plus nor a minus for Amarin
Lizzy...Nissen's position at Cleveland clinic depends, in part, on his fund raising abilities...His reputation took a hit from the failure of Epanova and the success of Vascepa...Anything that he can now come up with to correct his record of errors,perpetrated on the Cleveland clinic and AZN, can begin to make a path towards restoring his status as a prescient scientist.
Nissen is like a dog, who is scolded for peeing on a rose bush and then responds by barking at the bush.
Kiwi...Lost in all these discussions of MO and Vascepa are its PROVEN effectiveness in reducing CVD plus a PROVEN positive safety profile...as against the UNPROVEN negative safety profile of MO...in its use as a placebo in the R-IT study in a dose of one teaspoonful/day(i.e. 4 grams/day).
This seems to be less a matter of science and more a matter of dubious and unfair criticism.
CBB...I assume that a lot of subscriptions for STAT come from sensational exposes...and I assume that AF is manufacturing a misleading, at best, MO expose of Vascepa with the intent of profitting from it.
Statins also have their critics...QUOTE..."Statins do not address the underlying cause of heart disease: Chronic inflammation....
Statins may lower cholesterol, but they do not address the underlying cause of heart disease, which is typically chronic inflammation (some people are genetically predisposed to cardiovascular disease). The body uses cholesterol to repair arteries damaged by inflammation — the primary cause of heart attacks and strokes."
Vascepa works to reduce heart attacks by increasing statins' effect on lowering LDL and combining that effect with decreasing inflammation.
There was NO MINERAL OIL placebo in Jellis. Evaporate and Cherry... these successful studies are soon be confirmed by Mitigate and Respect...Does anyone really think that a combination of all these studies, proving that Vascepa is a safe and effective drug, will then stop Nissen and his friends from continuing to refer to Vascepa as an unproven fish oil?...I doubt it...not while Nissen is still smarting and seeing his status diminished from the failure of his Strength study, in which AZN lost hundreds of millions, by acting on his recommendations.... and, also while Feuerstein is enjoying the profits from his Stat tip sheet.
dogn...QUOTE..."The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood WHO ARE ALREADY TAKING STATINS"
580K bot in one trade...at the asked, a few minutes ago....this was probably not a retail investor, who spent 800K to buy Amarin today....I wonder who could have been the buyer....I'm guessing Denner.
I am anxiously awaiting Dr. Denner's next move.
lizzy...QUOTE...Teva makes no mention that "skinny" labels often consciously infringe on "robust" labels... in order to steal the exclusivity that was intended to encourage brand companies to spend billions of dollars in researching new transformative therapies .
QUOTE..."The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitment, including to manufacturing infrastructure such as dedicated facilities, to ensure sufficient capacity is available when needed."
Amarin was anticipating a larger need for API before Judge Du allowed the generic companies to infringe on their CVD patents.
When necessary cutbacks in investments in the marketing of Vascepa by Amarin occurred, sales volumes of this life saving drug dropped...Generic companies have found that is more profitable to just steal drugs rather than to invest in them.
A mere 650K of Amarin traded by 11 A.M( lowest volume seen in a while)...Of these, 315K were traded on the upside, in one minute, on the asked....? Denner at work...It certainly wasn't Eckman!
HDG...Thank you for for your accurate prediction...However, not everyone, including those on W.S., have a crystal ball and may have been worried that, prior to today's NICE report, the mineral oil mirage might affect Vascepa reimbursements.
HDG...as I recall, the final approval of Vaskepa by NICE came in early June...but the reimbursement figures came out only today.
In the midst of the MO controversy stoked by Dr. Nissen, there was some apprehension as to what the price would be in the U.K....This issue has been clarified today....and the outcome was good for Amarin.
C...My non-professional take on your dilemma...Both the Dow and the Nasdaq futures are down today, so Amarin may be down too...If the price goes down to...or, lower than, your selling price...in spite of the good news from Europe, I personally would buy back the stock.
Some of best buys were when I have sold in disgust at the price action...and then bot back soon after...usually at a higher price.
Good News from NICE...They agreed that Vaskepa was effective and they also agreed to reimburse at a reasonable rate...all the while, not paying attention to Dr. Nessen's misleading remarks.
Bio...QUOTE...article from Mar1, 2021..."During 2019, Pfizer’s Lipitor generated nearly two billion U.S. dollars of revenue."...
This is an example of what Pfizer could do with an AG Vascepa.
The price of Lipitor is low, but the volume is great, even in the face of MANY generic competitors.
A once or twice a day, patent protected, Lipitor-Vascepa combo drug would also help revenues...which would flow directly to Pfizer's bottom line.
sleven...If Europe and China don't come through in a year, Amarin will then need to institute huge changes to their marketing strategies....this means slashing expenses and prices to the bone...plus releasing an AG and placing dependence on increased sale volumes.
IMHO this policy would have a better chance of success if Amarin were owned by a BP...
A combination of judge Du and the three stooges (Feuerstein, Herper, and Nessen) have brought this dilemma about... where an effective drug to combat CVD will denied to most patients.
KIWI... at first, I ignored my stable angina, which then progressed to an unstable angina and an MI...necessitating placement of a coronary stent 21 years ago....I have seen a lot of my investment deteriorate during my years in as an investor in Amarin, but I'm convinced that being on Vascepa for 7 years (which I began to take after I had a second MI with placement of two more stents) has played a role in gaining me extra time....along with credit to Lipitor, blood pressure meds and anti-clotting meds for 21 years.