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...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.
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.
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.
The market for treatments of diffuse large B-cell lymphoma is forecasted to reach $7.9 billion by 2030
QUOTE..from TalShu post # 414369 on 8/22/23..."Amarin has secured a worldwide priority claim to a lymph releasing composition of EPA(LR-Et-EPA technology/intervention and methods using the same to increase EPA uptake and/or prevent a number of diseases...including CANCER"
i assume Lymphoma would be a logical target for this form of EPA , since it gains access to the circulation through the lymph system...
In November of this year, we still do not know whether Amarin has any plans for this new molecule.
Thank you for your post CBB...I have lost weight from my previous weight of 195 lbs to 155 today while on Vascepa and a vegan diet.. I always attributed my weight loss to changes in my diet..but your post today made me wonder me if Vascepa might also have had something to do with it.
Pfizer quote from a Biopharma symposium on 11/9/23..."And the idea of getting involved with biotech companies earlier, it's a big part of what we've been starting to do. Your first question was about different ways in which we drive innovation. I'll give you one example of one of the things that we've started, and this is something that we launched about 18 months ago, it's called Pfizer Ignite. When you think about partnering with somebody, there's an entire spectrum of things that could be done from very early-stage collaborations to a full-on acquisition and every flavor in between".
Cardiac disease may go on for many years without there being any obvious signs, which are recognizable to the family or to loved ones...This is different from AD, in which signs may become quicky noticed by the family, even when AD is in its early stages...If a safe, effective, and affordable treatment, as Vascepa, is approved for AD, it will be used for more years and for more patients than is the case for 'silent' cardiac diseases.(i.e."silent' until they become full blown emergencies)
This is especially true if an education process is undertaken to inform the public that there is a treatment available for this cruel disease.
JR...If the FDA, on the basis of the Brave study, approves Vascepa for use in AD on the basis of that study alone, Denner will sell Amarin to a BP, which can better afford to take Vascepa to new heights through marketing...If the FDA insists on a longer study, Denner will sell Amarin to a BP ,which can better afford to conduct the new study.
Either way, Amarin gets sold to a BP.
JT saw many opportunities for Amarin to GIA, but judge Du put an end to these ideas.
NS...Thanks for this article...Amyloid deposition in the brain is a well recognized symptom of AD...It may precede recognized cognitive damage...The challenge is to reduce the new formation of amyloid or, at least, to inhibit it....while at the same time minimizing the decay of cognitive facilities.
Patience will be necessary...When I recommended Vascepa to a family member with established AZ it was quickly discontinued because the patient and his family did not see an immediate improvement in his cognition.
Kiwi..The Brave study was quite invasive...It would be very difficult to recruit a really large number of patient, who would agree to serial spinal taps....In judging Vascepa as an effective treatment for AZ, the FDA will take into account the severity of Alzhheimers disease, the ubiquity of it, and the lack of any other effective, safe, and affordable treatments.
The main criticism of the Brave study has been and will be the small number of patients in the study...Lab work is being accompanied by psychology evaluations which are less quantifiable...The important assessment will be whether the Vascepa group did better than the placebo group in both the scientific and the "less scientific" assessments....My assessment is that...It is likely that the results will not reach statistical significance in a comparison between the active and the placebo groups...but the results will trend in favor of Vascepa being an effective treatment for Alzheimers...with placebo like side effects in a terribly disabling disease.
Whether this small study will be enough for the FDA and the EU to grant it validity without a larger study remains to be seen.
NS...QUOTE...from the University of Wisconsin..."Veterans are at an increased risk for Alzheimer's disease. The goal of the BRAVE study is to find out if a prescription strength dose of fish oil can stop or delay early brain changes associated with Alzheimer's disease."
This seems to me to be a clear description of the reason for the Brave study.
Billions have been spent by BP, without positive results...in attempts to prove that amyloid deposition in the brain is the cause of AZ...My thesis has been is that inflammatory vascular disease in the brain is the real CAUSE of AZ...and amyloid is actually a SYMPTOM, emanating from the destruction of neurons... rather than the cause.
The Brave study is poised to show that Vascepa, an anti-inflammatory drug, can be helpful to 'stop or delay' early brain changes associated with AZ....even in a cohort of pre-clinical patients...A positive trend in the Brave study in 'stopping or delaying' early brain changes in AZ will go a long way towards substantiating this thesis.
I believe that the amyloid levels in the cerebral spinal fluids of patients were measured during the study...as well as amounts of amyloid appearing in CAT scans...and these would be important in determining the risk or presence of AZ.
NS...QUOTE.." If Amarin can continue to open non US markets they should be able to establish a pricing advantage in the US"....
I was thinking along the same lines...i.e....With larger volumes of sales in the U.S. and Europe and ROW, Amarin can buy large amounts of API more cheaply than generics can... and consequently beat the generics on price in the U.S. and elsewhere....This advantage in pricing can be sustained even long after U.S. patents have expired.
Once the value of Vascepa is established in the world market, its importance as an anti-inflammatory drug will become more recognized and that should boost sales volumes even more.
A BP, buying Amarin, could run a larger study than the Brave study...to demonstrate statistical significance rather than just a positive trend.