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After the success of the Reduce-It study in showing that Vascepa reduced the incidence of CVD, Dr. Nissin had a selfish reputational interest in finding faults with the study...criticisms that have now been debunked.
After the Brave study shows amelioration of Alzheimers disease, the leaders, associated with several companies, will have selfish monetary interests, leading them to criticize the study, itself, and its results...The Brave researchers will need to have ready, detailed answers to counter the criticisms... IMO they are still painstakingly going through the time consuming process of evaluating the results of the study in order to counter these inevitable criticisms.
Jas...Thank you for researching that brief..."According to the district court, EPADI, as a non-party, lacked standing to file the rule 60 motion"
The fraud in the case still remains and a motion can be for a refiled by Amarin, to achieve a long denied justice in this case.The fraud here was not subjective or debatable..It was objective and criminal.
Pfizer is grossing 2 billion dollars/yr. in China from sales of Lipitor...There is no reason why Pfizer couldn't achieve similar gross sales in China from Vascepa....The two drugs go together hand in glove...The savings from reduced CVD in Chinese patients would more than justify the expense to the government heath care system for these drugs.
Bird...Quote... "Denner hopes that it becomes so clear by first quarter of 2025 that the company will return a growing and steady profit that he can shop the company to big pharma and get us a double-digit share price sale"
Positive results from China, where Vascepa has already gotten marketing approval...and from the Brave Alzheimers study in Wisconsin could provide additional help to Denner in his shopping Amarin for a decent share price sale.
In retrospect, Amarin's former BODs did a lot of harm to Amarin when they were at the helm...Its time for Amarin to catch a break with Denner and Holt in the present BOD.
We will never discover how the cropping of the study actually came about...but what we can know for sure...is that the fraud, which was critical for the judge's decision in the case, accounted for millions in profits for Hikma and millions in losses for Amarin.
ILT..While it is true that judge Du made an egregious error in the Hikma vs. Amarin patent litigation...It is also true that Kennedy, Amarin's chief legal counsel, Kennedy and the law firm Covington and Burling, Amarin's attorney's at the time, were also to blame for the oversight of not discovering the fraud that determined the case...i.e. the cropping of the bottom lines of the research study(unrecognized till afterwards), which was cited by the judge in her decision.
Kennedy and the Covington and Burling law firm have left Amarin, as have former Amarin management...it is now time for Denner to provide Amarin with standing for this case...the lack of which standing prevented attorney Michael Kasanoff's brilliant legal documents from ever being seriously considered by the court.
Fraud on the court has no time limit to appeal and this is a project worthy of being resuscitated.
Seagen, recently acquired by Pfizer, is a leader in Antibody Drug Conjugates(ADC's)...These are drugs, composed of antibodies,which seek out cancer cells...These antibodies have been linked chemically to cytotoxic compounds, which kill the cancer cells, while preserving normal cells.
This process inevitably produces inflammatory reactions...Vascepa as an anti-inflammatory drug, can ameliorate the consequent inflammation.
Pfizer is going all in on Seagen, having spent 43 billion dollars to do the deal...They might now consider spending considerably less to acquire Vascepa as an adjunct to ADC's...not to mention Vascepa's reduction of CVDs in the aged population, in which cancer is more common.
Seagen, recently acquired by Pfizer, is a leader in Antibody Drug Conjugates(ADC's)...These are drugs, composed of antibodies,which seek out cancer cells...These antibodies have been linked chemically to cytotoxic compounds, which kill the cancer cells, while preserving normal cells.
This process inevitably produces inflammatory reactions...Vascepa as an anti-inflammatory drug, can ameliorate the consequent inflammation.
Pfizer is going all in on Seagen, having spent 43 billion dollars to do the deal...They might now consider spending considerably less to acquire Vascepa as an adjunct to ADC's...not to mention Vascepa's reduction of CVDs in the aged population, in which cancer is more common.
Oncology Rx is developing rapidly...In acquiring Seagen, Pfizer has scooped up the the right deal at the right time.
Tats...Apparently, from your comments, you did not read my recent post...so I'll repeat it...QUOTE..."NICE recommends that only one omega-3 fatty acid compound is recommended in specific clinical circumstances – icosapent ethyl [Vazkepa®] (NICE TA805), and that all other omega-3 fatty acid compounds are NOT suitable for prescribing"
Astra Zeneca knows this from their expensive failure with Omacor...How come you don't?...You seem to be on team Nissin in bashing Vascepa.
Nsleven...Thanks....QUOTE..."NICE recommends that only one omega-3 fatty acid compound is recommended in specific clinical circumstances – icosapent ethyl [Vazkepa®] (NICE TA805), and that all other omega-3 fatty acid compounds are not suitable for prescribing"
Not only are Lovaza Rx's infringing on Amarin's CVD patents for EPA...They are a mixture of EPA and DHA, which have been proven to be ineffective in reducing CVD...CVD is the reason for which almost all Rx's for Lovaza are being prescribed....Lovaza is,however cheap, so no one cares...except for the families of patients, who die of CVD unnecessarily.
Is this a signal for all us hounds, who have been sniffing around...that it is now time to begin panting?
Tats...There are many interesting theories you discuss in your posts about Denner, which demonstrate your obvious acumen...one of most interesting questions, which is not discussed, is...Why are you posting at all about Amarin(i.e. what are your motives) ?
Patents encourage innovation...When the U.S government weakens patents, it weakens innovation...The U.S. has been the world leader in innovation of new life saving drugs.
Patents should not be treated as a political football.
Nsleven....IMO Tats is too intelligent to be wasting his time by posting frequently on this board...when he has zero interest in the stock, except to constantly bash it...I surmise that Tats' goal is to see Amarin's price drop...Longs on the board can only speculate on his reasons...but I do find him entertaining...except when he makes the most venomous statements about Denner.
Rose...Covington was Amarin's lawyer for the Anchor patent case and they erred in not detecting the cropping of an important study that swayed the judge to rule against Amarin(a croppted study she cited in her ruling)...Amarin's previous management had a relationship with Covington and put that relationship ahead of the interests of Amarin....and thus they chose not to be a party to a lawsuit, which would have reflected badly on their friends at Covington.
Dar...QUOTE..."The second shot Marjac took was ruled out as not having standing"....
If the case were refiled today by current management, Amarin would have the 'standing' they lacked previously...and I'm sure that attorney Michael Kasanoff(Marjac) of New Jersey would make his brilliant brief, pertaining to the fraud on the court, available to Provoost Amarin's new legal counsel.
QUOTE..."DUBLIN, Ireland and BRIDGEWATER, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the appointment of Jonathan Provoost as the Company's new Executive Vice President, Chief Legal & Compliance Officer. He will join the Company on November 15."
It will be interesting to see what this handsomely paid lawyer can do to get us out of this legal quagmire we are now in....especially in the case of the fraud on the ninth circuit court (a defect that has no time limits), in which the Amarin high trig patent was invalidated by judge Du due to fraudulent changes of the evidence (i.e. by the cropping of the report, submitted to the judge, of a vital study affecting the patent in order to skew her opinon...which cropped report, she then went on to cite in her opinion.
Marjac published an extensive and compelling brief on this injustice in the ninth circuit, a brief which Amarin's previous management chose to ignore at the time. ...If Provoost can help with this, his award will be more than justified.
YES...Amarin certainly does need an excellent attorney!
Tats...Quote from yesterday's announcement..."WE have never sold any shares of Amarin(AMRN) and have only increased our position since we made the investment."
Are you accusing Denner of being untruthful?
Today's message from Sarrissa was a warning to 2023 tax loss sellers...Amarin will not forever remain as low priced as it is now....so find some other losers to sell and keep your Amarin.
Over 3 million shares have changed hands,after hours, by 6:30 PM EST...Rapid upswings in price like this will always attract some sellers.
Tats...Supplements contain DHA and are subject to oxidation,which have been proven to counteract the ability of EPA to reduce the incidence of CVD.
Yes, there will be people, who will opt for the less expensive , but useless supplements, but Vascepa will remain the gold standard in a huge market.
Excellent letter...With you on the management team of Amarin,we would not be in the doldrums like where we are today.
When I asked my cardiologist at the Mass General Hospital in Boston to add an EPA blood test to my routine blood studies that he orders for me every 6 months, he replied that the hospital doesn't routinely do that test.(although he does prescribe Vascepa for me)...It is time for Amarin to detail hospitals and Docs on the importance of routine EPA blood tests to reduce CVD...
I have had two strokes and two heart attacks(prior to taking Vascepa)and have never had an EPA test.
Everyone knows about the importance of A1C blood levels in diabetes..but few know about the importance of EPA blood levels in CVD.
Patients know that they need to take Ozempic to lower their ALC...but patients are not aware that they need to take Vascepa to raise their EPA.
How about seeing performers on TV singing about their success in raising their EPA!
Tats...QUOTE..."Cost and side effects will not stop GLP-1 drugs from absolutely destroying V sales in the AD space"...
You must be kidding...Cost and Side effects always matter a great deal....Also, having AD stokes much more fear in patients than the fear of being overweight or diabetic.....I know because I have both relatives in my family, who are diabetic and overweight plus relatives, who have Alzheimers.
Diabetes and overweight are a nuisance...Alzheimers is a curse.
Incidentally, Diabetes and overweight are factors known to induce CVD...Vascepa has been proven to help with those also.
The Brave study includes measurements of amyloid in the brain and cerebro-spinal fluids over several years...as well as studies of cognition over the years. Brave is an unusually thorough study, being focused on whether Vascepa helps patients to avoid developing Alzhheimers disease or to ameliorate it, if it develops.
The University of Wisconsin medical school and the VA did this scientific study, which Amarin could not have afforded to do by itself.
Jas...QUOTE..."Current estimates are that about 5.8 million people in the United States have Alzheimer's disease and related dementias, including 5.6 million aged 65 and older and about 200,000 under age 65 with younger-onset Alzheimer's."
The study cited had only 47 patients diagnosed with dementia out of 15,820 patients in the study...This seems like an abnormally low number...The investigators were not specifically looking for dementia...The study was probably 'weighted' towards those under age 65...
It is difficult to draw conclusions from this study.
the cost of semaglutide...In the legitimate supply chain, the full price in the US is about $1350 for four weeks supply of injections
Compare this to Vascepa, which is a less expensive and safer drug than semaglutide...especially for elderly patients with Alzheimers disease.
Pdude...The Brave study was completed this September, 2023....The data is now being analyzed and should be ready for release prior to March of 2024...Positive results will set up a bidding war for Amarin, which IMO Denner is better able to oversee than the previous managers of Amarin.
This remains Denner's goal and our goal....an acquiring BP will make Vascepa into a global blockbuster.
Judge DU and Dr. Nissen provided the one-two punch that crippled Vascepa...Dr. Nissen wanted to deflect from his error in causing Astra -Zeneca to waist billions of dollars by his advice to AZ to purchase and study that failed drug, Omacor...and so he promoted the lie that the mineral placebo was the reason for the success of Vascepa in reducing CVD...and Judge Du desired to establish her credentials as a champion of inexpensive generic drugs...and so she invalidated Amarin's high Trig patent , knowing(or she should have known) that it would bring on unstoppable infringement of the CVD patent....even though over 90% of patients, who take Vascepa, are taking it to prevent CVD.
In the process. they caused patients to have unnecessary CVD's that could have been averted by the promotion of Vascepa by Amarin, enlightening more patients... which Amarin, unfortunately, has not been able to afford due to competition from generics,thereby limiting their cash flow.
The generics are definitely not going to fulfill this need to advertise Vascepa to make it better known by Doctors and patients.
ORB....Thank you for this article...QUOTE..."Therapies targeting late events in Alzheimer’s disease (AD), including aggregation of amyloid beta (Aß) and hyperphosphorylated tau, have largely failed, probably because they are given after significant neuronal damage has occurred."
BP's have wasted billions of dollars, which have been spent in failed studies...aiming to show that amyloid deposition is the cause if AD, rather than a symptom...The above quote shows the necessity of preventing the deposition of amyloid in the brain rather than removing it once it is present...If Vascepa can contribute to this result, it would be a safe and inexpensive step to solving a very resistant, debilitating problem, affecting millions of people throughout the world.
QUOTE..."Alzheimer’s disease starts in the brain many years before symptoms start to show. Early symptoms are mild and so don’t stop someone doing their normal everyday activities. It’s only later that symptoms become severe enough to be called ‘dementia’."
The participants in the Brave study will probably not have much in the way of cognitive malfunction...but they may have amyloid in their brain(i.e. on CAT scan) and/or in their spinal fluid(i.e. in the placebo group as opposed to the Vascepa group)...This could be sufficient data for the FDA to approve Vascepa as a safe drug for the treatment of any middle aged or older person with a family history of AD and with one of these markers.
Subsequent studies could show whether these amyloid markers..as well as cognition...improved over time with Vascepa treatment.
Amarin is my biggest investment and my biggest loser....I was preparing to sell Amarin shares in order to offset my capitol gains from this year..I got a call from my accountant, telling me that I had capitol losses from prior years that would offset my capitol gains for this year...so my present strategy is to hold Amarin for better days next year.
December can be a bad month to sell losing stocks...so IMO if you can hold Amarin through the holidays...do so....and December might be the right time to buy for those interested in buying Amarin...since the price might be artificially low this December...due to year end tax loss selling.
This might also be a good time for Sarissa to increase its ownership of Amarin shares at these prices.
Ns...Quote..."Who are these middle men, and how would they be involved?"
Middlemen that come to mind are....pharmacy chains, care giving institutions, and wholesalers.
I assume that the price that Amarin sets for their supply of Vascepa that they sell to Eddingpharm will be somewhat dependent on the price that the Chinese national health service agrees to pay Eddingpharm for prescriptions of Vascepa to patients.
If the price of Vascepa turns out to be really low in China, even Eddingpharm could become a middleman, selling to retail entities in countries where the price is higher...I assume that Amarin would not appreciate this....unless Amarin , themseles, choose to significantly lower their prices( i.e. by coming to market with an AG)..and simply intends to achieve increased sales volumes of Vascepa at decreased prices everywhere.
Ns...Without going too deeply into the weeds, price discrepancies between markets for the same product are an invitation for middlemen to move in.( e.g if the retail prices for Vascepa are much lower in China than in the U.S.)
Chrome...Quote..."We're thrilled to congratulate our partners, Eddingpharm, who have received confirmation that China’s NMPA has accepted its marketing application for a potential Cardiovascular Risk Reduction (CVRR) indication for VASCEPA (icosapent ethyl). This noteworthy milestone marks a significant step in advancing cardiovascular health for patients in China where cardiovascular disease is the leading cause of death."
Several questions now arise...
-What will the price of Vascepa be to individuals in China, who can afford to buy it out of pocket?
-What will be the price the national health service in China will agree to pay to Eddingpharm for Vascepa?....
-If that price is lower than that in the U.S. and in Europe, will some of the supply of Vascepa, intended for patients in China, find its way into the markets of other countries ...and if so, will that have an effect of Vascepa pricing outside of China(e.g. will it induce Amarin to consider an AG for the U.S.)?
Capt....QUOTE..."Under the agreement, Eddingpharm will be responsible for development and commercialization activities in the territory and associated expenses. Amarin will provide development assistance and be responsible for supplying finished, and later bulk, product. Terms of the agreement include up-front and milestone payments to Amarin of up to $169.0 million, including a non-refundable $15.0 million up-front payment and development, regulatory and sales-based milestone payments of up to an additional $154.0 million. Eddingpharm will also pay Amarin tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the high teens. Amarin will supply product to Eddingpharm under negotiated supply terms."
I am thinking that this development is a long awaited stimulus for the sale of Amarin to a BP, which can afford to do studies to develop and market Vascepa and other analogues of EPA ...such as LR-EtEPA, as a treatment for other indications such as dementias cancers, and inflammatory diseases.
Capt....It would be helpful if Amarin could send reprints of your post to cardiologists and insurance companies throughout the U.S....Excellent work!