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You are a legal expert and that is my question. How can the shareholders get Amarin onboard.
This is a slam dunk if the doubt around affected party can be eliminated by having Amarin part of the suit.
My fear is that the appeals judge may take the same stance around the affected party clause. Can shareholders bring this lawsuit on behalf of the company without they acknowleding it?
Their unwillingness to cooperate opens them up for much worse fiduciary lapses than the settlement issues you talked about.
Yes. They can be pursued. But this is not the time. In fact, it is the last resort to go after. Amarin needs to find a legal way to get back into rule 60. The stakeholder argument still needs more backing. Once they are in, the case is on a extremely solid footing.
What are the legal ways that Amarin can be FORCED into the case?
Also, if we think about what it brings to the shareholders , the answer is nothing. Even clawing back JTs compensation may not happen. Shareholders gain nothing.
@marjac
Independent of what happened in the past, it is done now. Establishing a direct line to Karim to pursue all patent litigation option with the support of Amrn is the right path forward. Filing an amicus in support of Rul60/24 or whatever the company can do should be done.
Making the Reduce-It patent, skinny label a more national discussion across pharma to drum up support is the next thing
As US waits, putting forth a solid global strategy is the third thing.
Anything other than this is just a waste of time.
Thank yoy
@rarafun would you happen to the average weekly scripts of Vascepa prior to Mid -2019.
I am just trying to guage how the TG market was before the CVOT buzz and Reduce-It.
What % of the true TG market is now captured by generics ? The current 10% does not indicate the true capture.
@marjac
Have you reviewed this case and was it incorporate in the filing?
https://www.jdsupra.com/legalnews/judgment-vacated-under-rule-60-b-3-8286782/
This directly goes into the heart of the Amarin / Hikma case and the fraud around misrepresentation of data. The court also agreed that if the plaintiff incompetence could not recognize the fraud but it was later proven to be true, the fraud still holds
The Federal Circuit recently affirmed a district court ruling setting aside a final judgment of patent infringement, including a $1.1 million damages award and a permanent injunction. The appellee brought the motion to vacate the judgment under Federal Rule of Civil Procedure 60(b)(3), which states:
(b) Grounds for Relief from a Final Judgment, Order, or Proceeding. On motion and just terms, the court may relieve a party or its legal representative from a final judgment, order, or proceeding for the following reasons:
. . .
(3) fraud (whether previously called intrinsic or extrinsic), misrepresentation, or misconduct by an opposing party; . . . .1
A motion under Rule 60(b)(3) “must be made within a reasonable time,” “no more than a year after the entry of judgment.”2
I agree.
Patent reversal
Reduce - it infringement legal fight
EU expansion are the only logical path to pursue
@marjac
You may find value in this case as you work on the appeal.
https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1063&context=nulr_online
This is interesting. However the motion was denied. @marjac Are there any instances of granting Rule60?
Absolutely! On the same lines, every business is a crook.
Is Hikmaa “intentional “ crook when it comes to quality? Always a possibility. What is the probability of the same? Almost nil!
However, our discussion that generic is not same as branded is just based fiction. I am not saying this can not happen. All i am saying is there are mfg safe guards to prevent it from happening. The assertion that generic is not same a brand is not grounded in reality.
J&J issued a recall of all its sunscreen products. Did they do it on purpose? Did they include carcinogens in its products? Could they have hid it? Were they more concerned about liability and damage because of inaction?
When you look at information objectively, out approach does not make sense. Better to focus on the company and its strategy to fight competition.
Rule 60/ 24
Reduce it patent fight
Europe
Sales marketing to capture US market
Cornering payers, etc
Generics are held to the same standards as brand. The API and finished product needs to meet all the same standards
https://www.fda.gov/files/drugs/published/Q4B-Annex-6--Uniformity-of-Dosage-Units-General-Chapter.pdf
I did not respond to this. Fda requires full GLP validation and documentation of all the mfg processes.
No company will take the risk of producing a substandard product “intentionally “. The fines are too massive, including plant shutdown.
Fda has detailed guidance on weight and content uniformity. A company will not compromise these GLP standards. They also have strict GLP guidelines around API and other processes
Can controls fail? Yes
Can inline management screw up? Most definitely. But these are different issues
What the hell is going on with the stock price? JT wants to dump and run away with his loot ?
Looks like Amarin insiders and directors have one primary job.
Collect Options based compensations
Ekman Lars for example is just pulling compensation from
Amarin
Untragenyx
Prothena
Sparkx
Now that is a cushy lifestyle
https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000897448&type=&dateb=&owner=include&count=40&search_text=
In complete agreement.
And the reason?
Treatment that does not work and swells the brain is better than no treatment?
We can have different threshold but not different scientific and statistical standard.
If yes, what makes quacks different from FDA. They too have standards
In my opinion Amarin should jsut ask for COvid indication because
there is no data to conclusive prove the evidence does not exist.
So approve.
Webster-
I do not disagree. Precisely the point
Biomarker reduction DOES NOT equate to Event reduction
Hence CVOT to prove correlation causation.
Amarin did a good job and FDA was vigilant to insist on a CVOT to support it.
I am taking about #aducanumab. Biogen showed that Biomarker reduction DOES NOT improve cognition.
FDA is insistent that biomaker reduction is an indicator of improved congnition despite proven flase. The approved aducanumab.
I understand the science. I am just explaning the logical fallacies of FDA.
At this time the regulatory agency is nothing more than a KINGMAKER with power. They do not work on evidence.
Same with our legal system and Amarin patents.
They do not decide based on evidence and law but the whims and fancy of the judge and their mood and may be bribes
Understand Sarcasm!
Regarding one-off, no it is not the case.
FDA new mantra is an absence of evidence is NOT the evidence of absence, so approve.
Why did Vascepa need CVOT trial? Was the biomarker evidence not enough?
So now we will get subjective and say there are other drugs to treat CVD. Are less people dying? NO. Is CVD an UNMET need? Yes.
So we should not need CVOT trials. But the fact is we should do them. Killing people financially for no benefit is same as a robber coming in your house, taking all your money and then killing you.
Here is a recent one that is minting money for decades without evidence of efficacy.
FDA still allowed this drug to continue. KEYTRUDA - despite that the KEYNOTE-361 trial failed to confirm clinical benefit in the first-line setting and the landscape has changed with the approval of avelumab (Bavencio; EMD Serono, Pfizer) as maintenance therapy — due to the lack of therapies that otherwise would be available for patients ineligible for platinum-based chemotherapy.
IR should remind FDA that they do not need evidence for drug approval. Likelyhood of benefit is more than adequate to approve a drug.
They can show hCRP reduction with Vascepa is similar to amyloid beta IN AZ.
So they should approve immediately under EUA.
Good point. If they decide not to cover, they are signaling guilt which will be damaging for the case.they are better off maintaining status co.
Looks like I am still allowed to post and not banned.
Number Seleven thanks :)
My last late-breaking comment and then we can come to discuss legal and other scientific questions around Vascepa
Rafeal Diaz, MD is presenting Prepare-it under late-breaking category for the following reason:
First presentation of primary endpoin!
Not because it is positive, "trending" positive or settles a long-standing debate.
The Call for Late-Breaking Science includes the following types of submissions:
LATE-BREAKING CLINICAL TRIAL - Reserved for first presentations of the primary endpoint(s) of a new clinical trial
I can buy it but don't want to. You are my last post (15/15).
It will keep me in check and give me another day to talk about science even if it is annoying :)
If people are to make buying and selling decisions based on posts from people like me, they should rethink investing. Also, if these posts are to move stocks, the manipulators will make the most of it knowing how fickle the shareholders can be.
When you get information, use it to dig holes in your thesis not bash it.
cheers.
Yup. My 14th one your way :)
"You have written 13 posts today and have 2 remaining."
I am reaching my daily quota and may not be able to respond.
In full agreement! BUT Vascepa long-term business prospects has nothing to do with Covid19. It is all about CVD.
Covid may be important. But it is a long road ahead and honestly in 18 months world will forget about Covid. Human memory is short. Regarding the trials, there areholes that I just want to discuss.
The premise that our discussion will bring stock price down, anyone providing Contra view is short and spreading FUD is just silly. If we want to debate science , legal issues, patents, let us do it with a open mind.
Someone claiming I am aligned with Hikma hence on the board is in a bubble.
There could be tons of new indications but primary physician can prescribe generic for any damn thing!
The issue is patents. Why is US market important? $$
Without limiting generics, capturing market is going to be a challenge.
Supply demand eventually reaches equilibrium. If generics feel that they have access to US markets for EPA they will find the way if the know that they are safe legally.
They will all go to FDA and say, you decide the label, the orange book code. We will accept it. If you do not give AB code based on guidelines, we will challenge it.
All we will tell the doctor is that generic contains the same dose and active ingredients as Vascepa, nothing more.
Again my credentials are IRRELEVANT!
FDA approved Biogen drug two weeks ago based on ? Definitely not data or science but debunked hypotesis that was proven wrong in the trials based on which approval was sought. Talk about credentials.
You believe VASCEPA works in Covid19. I believe there is a hypotesis to test nothing more. At this point there is no data to support it.
Back to EPA and oxidation. Even the lousy supplements ( not FDA approved drugs) "claim" that they meet the oxidation standards. Insisting generics do not meet FDA quality standards is silly in my opinion. You may be right but current information does not support the belief. I do not know the quality of this publication but just one instance where they claim that even the OTC supplements meet high standards .
More than 2,000 test results available from the scientific literature, third-party testing labs, and GOED's industry monitoring program show that more than 94% of omega-3 products meet the stricter GOED limits for peroxide value and nearly 98% meet the limit for p-anisidine value.
https://onlinelibrary.wiley.com/doi/full/10.1002/lite.201600013
Looks like I will be running out of posts today. So if I do not respond , it is only because I can not post anymore for the day.
Finally, our individual position in the stock is irrelevant because it has no impact on the information we are discussing. The stock price will impact our finances but not the science. A low stock price does not invalidate the patent. The fight is on.
A high stock price does not automatically grant approval for covid19
use.
If any of this were to happen Baker brothers should be calling the shots not Amarin, US courts or FDA.
Cheers
Ralphey- in complete agreement!!
When I read the posts I read the message not who posted. Is there value in the message? Do I need to understand it more? Why does the alternate differ from mine?
I do not talk anything but sciemce. Questioning is different from speculation and accusation.
I dug some holes in Cardiolink-9 , which does not fit the narrative of this board.
When baseline symptoms are not matched for biomarkers and symptoms and there is a open label trial, it is nothing but hypothesis generating endpoint. That is what Cardiolink-19 was and nothing more.
I could be wrong , so no big deal.
I honestly thought so !
But I forgot that our justice system does not work on science but hubris. Same with FDA. Who knew judges will ignore facts and go with Du 's fiction?
Regarding generics - yes they meet all standards set by FDA. Failure of compliance is intentional and comes with great risk. If generics are not equivalent, then FDA is not doing its job and the Mfg are not scared of enforcement of being shut down.
Everything for HCQ, Ivermectin, magnetic fields have been shown to work somewhere with Covid19. May be Vascepa will work but we have a long way to go.
CVD works and we are no where with where the sales should be.
Regarding oxidation- Majority of the drugs ( considered by body as foreign chemicals) need to be removed from.the body. Body works very hard to do that. It does it by phase I OXIDATION followed by phase II in the liver
Sometimes, the drug is directly removed in the kidney. So yes oxidation inside the body has a purpose
Regarding oxidation of generic drug in a bottle. If the drug does not meet the shelf life , expiration guidelines, the product should not be on the market. Again FDA IS NOT DOING ITS JOB. If the company knows that they are marketing expired products based on their quality control, then it is a criminal.offense.
I hope I answered all your questions
Invest- you are free to block me. No issues.
My contributions are based on my understanding of information. I interact Rara, Seleven, posted , etc.
We are debating what late-breaking means, where Prepare it is heading , what the recent cardio link 9 Means , etc.
Just because I am presenting an alternate view point of the same data BASED ON FACTS that does not suit the narrative, does not make it wrong.
We all can have rational debate if we ignore the messenger and focus on the message.
For eg, Rara was talking about cardio link which is open label trial
The biomarker endpoint values reported were MEDIAN not mean. They do not compare Vadcepa and placebo ( similar to Mori) but 0 to 14 days. Should we not question it? Or the question is valid only for Rule24/60?
The base line characteristics are different ? We OK?
For clinical endpoints, the baseline for sorerthroat , loss of smell, difficulty breathing are all different at baseline and statistically significant. How can you conclude that the improvement is because of drug?
Debate the message , do not shoot the messenger.
Why am I doing this? CVD is the area that will have impact. Covid19, though important, is just a transitionary phase. Will the drug have more indications? May be, but it is years away.
Will Prepare it show great results? May be , but we have a long way to go!
John Gnatt.
Now do day 14 Vascepa to day 14 placebo for all the end points.
Is the goal to show Vascepa is better than itself over 14 days?
Or is the goal to show that Vascepa is better than placebo at day 14?
It looks like you are in agreement with Judge Du, who showed that Mori,, Hayashi and Kura were all statistically significant endpoint's similar to Prepare it.
We discussed this yesterday and I argued that similar to Mori, we not want to compare 0 days to 14 days baseline comparison.
When the real comparison is 14 day Vascepa to 14 day placebo.
Did we not fight to say that that Judge Du made errors because she does not understand statistics. Did Bhatt not argue the same with his paper?
In cardio
Baseline was 3.9 (0.9-11.6) for vascepa to 2.3 (0.7 - 6.5 ) for placebo.
The groups at baseline are NOT matched. DATA IS NOT MEAN and stdev but MEDIAN and IQ range !!! Why?
At day 14, it is 1.6 (0.6-4.4) to 2.1(0.5 - 5.8), respectively
Is it easier to lose weight when you are 450 lbs or 150 lbs?
If we do a t-test BETWEEN groups, the results will not be significant. Infact, P-value BETWEEN GROUPS is 0.082
Why is it trending to significance? MISMATCHED GROUPS. If you do a t-test at day 0, the groups are statistically different. I can not prove it because the data is media and not mean with stdev.
Now tell me this is all FUD and
Median and inter quartile is the right way to present data for a t-test.
Comparing baseline to end point is the right thing to do.
Comparing vascepa to palcebo at end of trail is FUD
We can go on.
It all started with late-breaking.
How do your 10 -100K shares impact anything that happens at the conference?
Me being long 100K or short 100K has no impact either.
If you think that people on the board will sell based on FUD from any person (including me if you are inclined to say so), should not be invested in the company.
I am not preaching anything. All I am trying to convey manage things that are in your control. Influence things that we can and stop speculating on things over which we have no control.
Skin in the game from Taleb sounds great but has real-world limitations.
The only people that have skin in the game are politicians. They have to work hard to hold on to their seat. If they can not make that happen, their primary purpose of existence in this world to live a life full of corruption and debauchery is lost. Their existence becomes meaningless. Hence they work so hard decade after decade.
I already answered your question in a different post.
Yes, not everyone posting should be a shareholder ( I am but that is irrelevant)
Also, not everything that is questioned or corrected or debated is FUD as some noted or short sellers (again onwership is irrelevant)
Questions requiring a change of viewpoint or providing an alternate perspective does not make it right or wrong. It has to be weighed against what is known to inform individual thought processes.
Whether "Prepare it" is positive or negative is not dependent on whether I question the late-breaking status or someone assumes that late-breaking means positive.
Neither our share ownership is going to matter. The issue is trying to guess that late-breaking designation means something good is coming, something important is happening is wrong.
When it comes to patent defense, that is something we can try keep fighting if we have "skin in the game". WHY? Because, this is the only outcome where there is the possibility of some chance for @marjac to prevail if Rule 24/60 is given due consideration.
Another area where the skin in the game matters is management accountability. For all other outcomes, including a BP buyout, we are just speculating and building castles in the air.
All of you are missing the point. My or your skin in the game is meaningless. JT's skin in the game has some meaning but he did not use his skin. It was all collectively borrowed skin from all the shareholders ( the stock compensation, options, etc), so even he has borrowed skin in the game.
So again, it does not matter whether I own 1 share or 10,000 shares. I can not influence the endpoint of a trial by my ownership. Neither can you.
@marjac is trying to influence the outcome of the patent fight and we are all supporting it.
Other than that we can not do much. Even we praying day and night that Prepare It is positive is not going to matter. The results will be what they are. stock ownership will not influence that decision.
If that was the case JT and Baker brothers would have handed the patent win just on ownership. It did not happen right?
So again, do bother with what is the skin in the game story. If you and I were running Amarin than that was important. As shareholders we are passive participants.
Regarding ownership opinion. It is meaningless. We always try to guage the message through the wrong lens.
I have a stake in Amarin (long) but I could be bluffing, right? It should be irrelevant
All I am trying to convey to all of you is anything related to Covid19 is late- breaking. There is no practical way to generate the data necessary that meets the conventional deadline of these big conferences by their due dates
Furthermore, IRB requires that human studies when conducted better understand important questions. Otherwise, it is unethical to do these studies. Who would not want to know if a drug (any drug) works in covid19? If someone is trying to do it, is that not an important question.
Whether the trial worked or failed is not the reason why a late breaking designation is assigned.
We can disagree but to insist that the Argentinian guys will not present data unless it is positive or trending positive is naive.
@Sleven - YES. Down 50% though. I could not post earlier because I reached the 15 message limit.
@Pharmacydude- Do not shoot the messenger
@Meoza - Go to clin trial gov. Here is the sponsor and collaborator section
Sponsors and Collaborators
Estudios Clínicos Latino América
Amarin Pharma Inc.
Amarin is a COLLABORATOR. It is upto you to decide what a collaborator means. For all practical purposes, a collaborator works together with another party. We will only know what was the role of the collaborator until the paper is published and the financial interests are disclosed along with the role of all the authors.
I will insist again that late-breaking does not mean much. Every Covid-19 study has significant importance because of the period we live in.
Most Covid19 studies will not be able to meet the 4-6 month deadlines for abstract submission. They will NOT have data.
Everyone understands that. Hence the late-breaking concept.
Done.
Joint American College of Cardiology and Journal of the American College of Cardiology Late-Breaking Clinical Trials I
Saturday, May 15, 9 – 10 a.m. ET
• PARADISE-MI: Sacubitril/valsartan (Entresto) DID NOT significantly reduce the rate of heart failure or cardiovascular death following a heart attack compared to ramipril. Prospective ARNI vs. ACE Inhibitor Trial To Determine Superiority In Reducing Heart Failure Events After Myocardial Infarction. Presented by Marc Pfeffer.
• ADAPTABLE Study: Aspirin 81mg vs. 325mg shows NO difference in outcomes. Dosing: A Patient-centric Trial Assessing Benefits And Long-term Effectiveness Trial. Presented by William Schuyler Jones.
• Effects Of Dapagliflozin DID NOT Aid Prevention Of Major Clinical Events And Recovery In Patients With Respiratory Failure Due To COVID-19 - Main Results From The DARE-19 Randomized Trial. Presented by Mikhail Kosiborod.
• The FLOWER-MI Randomized Trial: No Benefit Found for FFR-guided vs. Angio-guided Multivessel Revascularization In ST-Elevation Myocardial Infarction Patients. Presented by Etienne Puymirat.
Finally if Covid-19 results are impressive and we have a global epidemic raging, should a company wait to present data or or run to FDA and demand EUA based on the data?
Honestly, given the urgency of the situation what will you do ?
Go to FDA
Submit an abstract for late breaking designation.
Think and let me know what is the right thing to do.
I looked at the ASCO website which has tons of late breakers
Phase II AND III studies for which NO DATA ARE AVAILABLE at the time of submission.
The practice changing implication only because these mega conferences have the largest EYEBALLS to offer.
The ASCO late-breaking data policy allows for the submission of late-breaking data only for:
Randomized phase II and III trials for which no preliminary data are available at the time of the abstract submission deadline (February 17, 2021);
OR
Original research studies that highlight novel and high-impact research with practice-changing implications