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jasbg...KM and Marks are recent hires and do not yet have the clout to go against the BOD...but I would not be too surprised if one or both of them resigned in protest to this flagrant abuse of shareholder's interests...I feel like we shareholders are afloat in a turbulent sea, sitting in a dinghy and waiting for the waves to waft over us.
China will add cash to Amarin's balance sheet plus prestige to Vascepa for being used in large volumes...and help acceptance in ROW
Tal...You might consider adjusting your daily dosage of Vascepa upwards from 4gms/day....8 grams/day has been proven safe in a recent study...I wish you a safe and rapid recovery.
From the Brave study "The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by 2050. Compared to the general population, Veterans have a greater risk of AD, likely in part due to their increased incidence of traumatic brain injury, post-traumatic stress disorder, depression, and other vascular-related health issues. Thus, the discovery of effective therapies to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs"
My understanding that Veterans with PTSD have an increased incidence of AD....This motivated the VA to study AD in veterans with PTSD....but the results of Vascepa treatment to prevent or ameliorate AD would be applicable to any other populations.
Statistical significance means everything to a study...unless we are referring to the Kurabayashi study which was NS(non-statistically significant) and was quoted verbatim in Judge's decision to invalidate the Marine patents.
Look at what happened in Prepare-it 2, which was trending highly positive, but still NS and was disregarded...even though the Cardiolink study HAD previously reached statistical significance.
N sleven...The Brave study was scheduled to be competed last month...The fact that it has been continued until January 2023 suggests to me that the VA is on to some good results, but would like to wait for statistical significance....If this small study can show stat. significance...and since Vascepa has a proven proven track record of safety), Amarin can apply for emergency use authorization before having to complete larger studies.
Vascepa could be a superior treatment for Alzheimers than the $56 thousand a year per patient Aducanumab, which was recently approved for use in Alzheimers disease.
My personal explanation, having had stenting to make AF go away...and having been on Vascepa since with no recurrence of AF.
AF is due to interruption of electrical flow to the entire myocardium by an area of focal dead(or dying) myocardium...
With a generally more healthy myocardium(due to Vascepa), impulses from the dead area are spread across the healthier areas more readily and cause an increase in abnormal rhythm.(the dead focus area is still dead, but the rest of the myocardium is improved by Vascepa).
It is now becoming increasingly untenable for a small Biotech to formulate and research a new product, fund it through the several required phases of tests,get FDA approvals, and then to sustain the attacks from generics seeking to capitalize on the hard work and risks that went into bringing the product to market....Big pharmas with multiple products and huge financial assets are better prepared to do these tasks....The USPTO, the FDA, and the legal system have all but closed the books on the ability of small pharmas to swim against the legal and political tides.
Lars Eckman, COB for Amarin since 2008 has a bunch of other important and interesting positions and associations..e.g....
1.Sofinnova partners 14 years....description...
PARIS--(BUSINESS WIRE)--Sofinnova Partners, a leading European life sciences venture capital firm based in Paris, London and Milan, announced today the close of its latest early-stage healthcare venture capital fund, Sofinnova Capital X, oversubscribed at €472 ($548) million. This brings the total amount the VC has raised to €1 billion in the last 12 months across its multi-fund platform, and the total AUM to over €2.5 BILLION. Capital X, the 10th iteration of Sofinnova Partners’ flagship fund, is the largest healthcare fund dedicated to early-stage investments and company creation in Europe
2. Elan Pharma...for 14 years
3.Schwarz Pharma for 5 years
4.EVP of R&D...PharmaciaGmbH for 6 years
5.Chairman of BOD and executive partner of Prothera for 9 years
Given all these irons in the fire, I imagine that Eckman would not want to get involved in a messy rule 60/24 appeal with Amarin vs. Hickma...This may be the reason he has held back Amarin's support for the rule 60/24 case...EVEN IF THIS WITHHOLDING OF SUPPORT IS TO THE DETRIMENT OF AMARIN SHAREHOLDERS.
Nsleven ...The PTAB is well known its proclivity to produce anti-patent decisions...Since Hickma understands that Vascepa is destined to become a global blockbuster drug, I am not surprised that Hickma is willing to invest heavily to invalidate any Vascepa patents they might able to.
This situation illustrates the necessity for Amarin to support, not only the PTAB case, but also the rule 60/24 case.
Hickma has declared war on Amarin and is willing to expend any resources necessary for its success in grabbing the Vascepa markets.
If Amarin is unwilling to counter, in this battle, with as strong a response as possible, they should sell out to a BP that IS willing to provide a strong response...A weak response from Amarin would be self defeating.
Nsleven...There are two separate cases involved here.
The rule 60 case asserts that a fraud/mistake influenced the court to invalidate the high triglyceride patents...
The Hickma-Healthnet case, asserts that there was infringement of the CVD patents... Judge Hall has already decided on non-dismissal...It now awaits the decision of Judge Andrews as to whether to concur with judge Hall's dismissal verdict or to proceed with the case.
The Hickma appeal to the PTAB to invalidate the CVD patents should not be allowed to forestall a decision on the rule 60 fraud/mistake case concerning the high triglyceride patents...nor the decision as to whether to proceed with or dismiss the Hickma/Healthnet case, concerning infringement of the CVD patents.
In both cases, there should not be a delay caused by Hickma's appeal of the CVD patents to the PTAB
A prescription for Vascepa should be given to patients to be taken 2 grams,4 times/day, at least two or three days before mrna shots...to prevent vascular complications from the vaccinations.
Robin...I was not taking Vascepa during the period when I had two bouts of rapid atrial fibrillation...I was treated twice with cardioversion(electric shock to the heart) in an effort to stop the AtFib, but to no avail... I then had percutaneous intervention with placement of two coronary stents...This stopped the atrial fibrillation and I have not has a recurrence of that for about 6 years since...Among other meds, I am on Vascepa 4 grams/day, with Eliquis having been recently prescribed to replace the heparin that I was on for 20 years since my first heart attack and my first stent.
Could...IMO, with Pfizer having plenty of cash and an interest in Vascepa...and Amarin presently in a position of hurt, discussions of a BO of Amarin are now ongoing...A price for Amarin of about $15/sh, plus or minus one or two points, would seen to be a bargain for Pfizer and, at the same time, lift Amarin out of a deep hole, where they are at present... It would be a good deal for both parties and for patients.
Compromise is often difficult and drawn out...but I believe a BO will eventually get done.
C
QUOTES from ICER "Icosapent ethyl Vascepa Cardiovascular disease prevention yearly cost... $3,241
maximum yearly cost effective price...$9,500"(i.e. this is what the average yearly cost for patients,who are not taking Vascepa, but are candidates for it( i.e. due to their increased incidence of CVD without Vascepa.)
The take away from these figures is that insurance companies save over 6000 dollars per year for themselves on each patient, who takes Vascepa.(this is not to mention the human misery they save patients and their families)
Hickma is contesting the R-IT patent, which is the patent for Vascepa to be used as a treatment for CVD...Hickma's contention will be that the Jelis study made it obvious that Vascepa was a treatment to reduce CVD.
In 2013,at the FDA anchor hearing, a panel of experts decided that it was NOT obvious that Vascepa was useful for CVD and they voted to deny approval until completion of the R-It study...Only after the completion of this study did it become obvious that Vascepa was a treatment for CVD
Hickma is now running scared because the potential of the rule 60 and the infringement suits to be decided against them.
Hickma is using this frivolous assault on the '077' patent as a bargaining chip to induce Amarin to settle with them in case Hickma loses the other legal cases against them.
Hickma has declared war on Amarin ...this is another reason why Amarin must fight them by joining the rule 60 case.
This is what I have wondered about...Would it be possible, at this late date, for Amarin to enter the case as a co-plaintiff?
Some of the cases brought up by Eight will also be cited in oral hearings by Hickma lawyers as a part of their defense...It would be helpful for EPADI to have the assistance of some Fish and Richardson patent specialists in supporting the EPADI case.
Eight(now Nine) may seem to be somewhat of a martinet....but that's what you have to be when you have nine kids.
It is my belief that Eight is long on Amarin and that he and Marjac will celebrate with us, after success in the rule 60 case.
I hope Eight returns to Ihub and posts again so we can continue to have these enlightening, even if somewhat unsettling, discussions.
lettruthringout "without the full legend the likelihood anyone could randomly pick the correct p value for USPTO overrule purposes is... as we've seen, statistically low"
You have extracted the most important statement in the Markman comments on the Amarin vs. Hickma trial.
Without the fraud/mistake cropping, of the Kura table, Judge Du would have had a different conclusion as to the 'obviousness' of the Marine patent.
Covington and Amarin were not aware of this cropping, which was vital to the whole case, until after Judge Du's decision.
eight...Singer made the reasonable error of basing his appeal on the Graham principles, which seemed to be in Amarin's favor...even though Singer was aware that some of the judges at the CAFC were not in agreement about the importance of the Graham principles.
The rule 60 appeal has as its basis the INDISPUTABLE FACTS that an important piece of evidence was altered(cropped) in the form that made its way verbatim into the rational for the judge's decision.
Hickma's lawyers are smart and they will put up a good defense, but I don't see how they can counteract these facts...or their effects on Judge Du's decision.
We at EPADI have been treated to a stimulating discussion, but I still respectfully maintain my positive view for our appeal.
LM...Covington is an ex-employee of Amarin and Kennedy is no longer part of management...Amarin's current management should be responsible to the interests its shareholders, not to the interests of Covington or Kennedy(who, along with the court, were duped by the fraud/mistake which steered the decision in the interests of Hickma).
This is a public plea to Amarin management to enlighten shareholders as to their reasons for their hesitancy to join EPADI in the rule 60/24 appeal.
EPADI shareholders can easily understand the upside that a successful outcome in this matter could portend...but need some assistance from management in understanding the downside.
If the present BOD of Amarin does not choose to join the rule 60/24 appeal until after the annual meeting in May...and the oral arguments are delayed until then, The BOD may be replaced with a new BOD, which could then choose to support EPADI...That would make the present issue of 'standing' moot.
Hickma figured they were accomplishing two things by their not responding to the EPADI brief in the rule 60 case...
1. they did not address the substance of the EPADI brief, which would have put them at a disadvantage...since it would have been hard to dispute that there was a fraud/mistake of importance to Judge Du's decision, as a part of which, the cropped Kura table was copied verbatim.
2. In the event that the court allowed standing, Hickma pretty much guaranteed that the court would allow them the opportunity to state their case in an oral argument....and not just decide the case on the briefs, which they suspected would go against them.
The reason why the cropped Kura table was so important to Judge Du's decision is: The two bottom lines cropped from the table indicated that the difference in APO-B between the active and passive arms of the Kura study was NS (i.e.non significant)
An increase in APO-B is associated with a lower triglyceride levels...which would make it OBVIOUS to a "Person of skill in the art" that EPA, if associated with an increase in APO-B, would result in lower triglycerides...BUT THE UNCROPPED KURA TABLE showed that there was NO INCREASE IN APO IN THE ACTIVE ARM....This is what made the cropping so important for judge Du's decision in favor of obviousness.(and therefore the invalidity of the Marine patent.
an explanation from Google "The low-density lipoprotein cholesterol/apolipoprotein B (LDL-C/apoB) ratio has conventionally been used as an index of the LDL-particle size. Smaller LDL-particle size is associated with triglyceride (TG) metabolism disorders"
Rose "The post-trial (but BEFORE decision) presentation of Hikma et al) had the cropped table and then of course the Du decision had the cropped table. Did Amarin have access to Hikma post trial brief and did they say anything about it? Don't think so?"
This is what I believe happened...Covington was duped and Judge Du was duped...Hickma should get the blame for this fraud/mistake...NOT Amarin or its lawyers...That's why I have difficulty understanding why Amarin has been apparently unwilling to purse the rule 60 case.
EPADI deserves an explanation and the court deserves an explanation.
The new chief legal officer of Amarin is John Marks....A description of him in Google includes the following: "he sees complex challenges, that others might fear, as exciting opportunities, and he relishes the opportunity to tackle them."
I relish the thought that the BOD of Amarin might give Attorney Marks the green lite to help with the rule 60 case.
EIE "In the event they lose the standing argument--they will ask the court leave to fully brief the reply--and court will grant it."
As I said previously, I would welcome an explanation from the Hickma attorneys about how they convinced Judge Du to copy VERBATIM a CROPPED KURABAYASHI table into her decision in favor of their position.
I believe Amarin and their shareholders have a right to hear this.
eight " Def.know judge will grant them opportunity to fully brief rule 60 if necessary"
I would welcome an explanation from the Hickma attorneys about how they convinced judge Du to copy VERBATIM a cropped KURABAYASHI table into her decision in favor of their position...Even if the explanation was "an error was made by someone in the court"...It would favor Amarin to win the rule 60 case...IMO this is why Hickma failed to reply to this issue in their brief, which contested the rule 60 case...They would much prefer the whole "error problem" be dismissed due to standing...and not embarrass themselves or the court.
could... I agree...It would be a worthwhile idea for every patient to be pre-treated with Vascepa for a few weeks to lesson potential adverse effects associated with vaccination.
This would reduce the number of reports concerning the side effects surrounding vaccination and encourage more people to get vaccinated.
Marjac...What is the period time, after which Amarin can not choose to partner in the Rule 60/24 case, even if it chooses to do so?
The Mitigate study by Kaiser has 16,000 randomized patients taking 4 grams/day of Vascepa... Mitigate is presently studying Covid for reduction in the same types of outcomes as previously studied in Cardiolink....which had statistically positive results for reductions in hospitalizations and deaths, and Prepare It, which was trending positive...when the money ran out to continue the study over a longer time period...i.e.in order to achieve the probable result of statistical significance.
Mitigate, which was commenced in August of 2020 has signified its primary completion to be date-Feb 2022...and its final completion date to be Feb-2023.
Stay tuned!...With Covid on the March, the Mitigate Cavalry could be called upon to join the Covid battle.
Eight...Wouldn't the court have to deal with the complex legal questions presented by rule 24 in this case before they could proceed to deal with the equally complex legal questions presented by rule 60?
To my mind, these are two separate important legal questions that need to be dealt with by the court separately.(although, of course, if the court finds EPADI has no legal standing in this case, it will never deal with the rule 60 fraud/mistake assertion.
shadolane "Refusing to acknowledge errors then correct them is at issue here. No matter how many should have caught them."
Judge Du was of the legal onion that EPADI did not have "standing" to bring the fraud/mistake appeal...therefore she did not have the opportunity to correct her error in the original case.
Our appeal of her finding has two components:
1. EPADI DOES have legal standing to petition the court to correct judge Du's error.
2. If the appeals court accepts that we have legal standing, it can either correct the error itself or refer it back to judge Du for correction.
h4...The Covington law firm had a plethora of associates, who had the responsibility to review every minute detail of the evidence presented in this important case...and failed to do so.....judge Du, as I recall, had but one clerk, who failed.
How about chances for Vascepa success for one or more of these initiatives in 2021-2022?
1. China
2. the infringement suit
3. the rule 60/24 suit
4. revenue in Europe
5. BO by BP
6. the Mitigate study
7. the Nash study
This is not to mention needed future studies that will never be funded by Generic companies..... such as a Vascepa treatment for:
-cancers(prostate, colon etc.)
-arthritis
-colitis
-dry eyes
-depression
-obesity
-and on and on....
Generic companies want to avoid the toils and just grab the spoils.
Canes "Dr. Heinecke's spurious testimony and the CROPPED TABLE are solid grounds to be sure".)i.e.for a rule 60 appeal
I always was of the impression that it was the duty of each attorney(whether for the plaintiff or the defense), who picks up a fraud or a glaring mistake, like the cropped table, to report that information to the court immediately...In this case, the fraud/mistake made it all the way into the decision, in which this critically misleading cropped table was quoted verbatim by the judge.
Marjac...Thank you for your post...In my layman's understanding of the rule 60/24 appeal, once we can get by the rule 24 part, we have a good chance of winning the rule 60 part...This is why I have been so frustrated with Amarin's unwillingness to join us in this fight.
The stakes for the shareholders are so high with a victory in this case...In my 50 years of investing, I have never been more put off with a management decision.
Lots, "PFE and HLS would certainly benefit if AMRN's patents were restored and perhaps media advertising resumed as American media would be seen by many Canadians."
Question...Would Pfizer, on the basis of their demonstrated interest in Vascepa, have the 'standing' to ally with EPADI in the rule 60 appeal?
Pfizer....short of acquiring Amarin, would still profit from a boost to their proceeds from the Canadian. market
A win in the rule 60 appeal for Amarin would allow Amarin to be able to afford to resume media advertising in the U.S.(which,as you say, would be seen by many patients in Canada) and add to Pfizer's Vascepa profits in Canada.
I think if Pfizer joined EPADI in the rule 60 suit, Amarin would also.
Capt...I suggest that this excellent summary of our EPADI dilemma be sent also to the Pfizer CEO, Albert Bourla.
Pfizer definitely has shown, by its contract with HLS to market Vascepa in Canada, that it has an interest in Amarin and could be having difficulty in negotiations with Amarin management and the BOD, whose interests apparently do not presently coincide with the interests of Amarin shareholders.