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Yes that would be putting your money where your mouth is .
Nissen prefers to open his mouth for the money
This irrefutable mechanistic evidence is what refutes the mineral oil conspiracy and all omega 3's are snake-oil hypothesis:
“With this unusual benefit seen in REDUCE-IT, you have to look at it carefully,” Nissen. “It is our belief that it is the comparator that is different. REDUCE-IT used a mineral oil comparator ... we think this is more evidence that REDUCE-IT is a false positive study driven by a comparator that had toxicity.”
Eight
Please explain how the request to correct a demonstrable factual error of evidence creates prejudice for the defendants whether or not frai=ud is reached?
Eight
I understand your point and thank you for your insight. Here is my question:
If the rule 60 petition had alleged catastrophic error ie mistake (and not fraud), would you say the same?
In the issue of standing and bias, how do you see this-please explain?
TO DENY STANDING TO A CASE THAT CLEARLY, METHODICALLY, AND WITH IRREFUTABLE SCIENTIFIC PROOF SHOWS CATASTROPHIC JUDGEMENTAL ERROR, CULPABLE MISTAKE AND VERY LIKELY FRAUD ON THE COURT IS LIKE DENYING STANDING TO ESCULPATORY EVIDENCE AND WATCHING AN INNOCENT MAN HANGED "FOR LACK OF STANDING"
DU HAS STANDING HERSELF LEAVE ALONE EPADI -SHE COULD HAVE AT LEAST ASKED IN PUBLIC FORUM HIKMA AND HEINECKE TO EXPLAIN THEIR STATISTICAL ASSERTIONS THEIR DISTORTIONS OF CLAIM CONSTRUCTION, AND WHAT HAPPENED TO THE TABLE LEGEND--NO, INSTEAD JUDGE DU TOOK THE EASY PATH: DENY DENY DENY, COVER UP THE ERROR, AND THEN OBSTRUCT THE CORRECTION O AN INJUSTICE--WORDS FAIL ME! THIS IS THE MOST REPREHENSIBLE ACT OF VENALITY AND MORAL COWARDICE EVER COMMITTED IN THE ANNALS OF PATENT LAW.
THE MISTAKE IS SO OVERWHELMINGLY OBVIOUS NO ONE WANTS TO ADDRESS IT. THE FINAL STRAW STRAW IN THIS IMBECILE JUDGEMENT IS THAT SHE STATES PARENTHETICALLY THAT AFTER A YEAR REVERSAL WOULD INCONVENIENCE THE DEFENDANTS UNFAIRLY IF SHE REVERSED HER DECISION.
I HAVE SO LITTLE FAITH IN THE JUDICIAL SYSTEM. CAFC WILL LIKELY RUBBER STAMP THE SAME NONSENSE THAT JUDGE DU JUST ENACTED USING TEH RULE 36 AS PER DYK ET AL LAST TIME. THE SCOTUS IS THE LAST HARBOR OF REFUGE--BUT DON'T COUNT ON THAT EITHER...OMNES TURCI
Amen
Truth conscience and justice VS. ego political bias and bigotry?
Zip
Agreed entirely. This case is a travesty of both the interpretation of patent law using the Graham principles and a travesty of scientific representation of prima facie evidence--on both accounts, it is a glaring embarrassment to the patent adjudication system and the legal process followed in both the district court of Nevada and the CAFC where in my opinion the greater blame for reckless disregard lies. Dyk et al have blood on their hands.
North
There is a lack of differentiation between "omega-3" and specifically EPA Icosapent Ethyl--this is a problem. Also, there is contamination by analysis for sudden arrhythmogenic sudden cardiac death which is quite another beast compared to MI CVA CV death..
HK
Rose
Simple venous and arterial duplex ultrasound of the lower extremities would tell you everything. Of course, neuropathy can give rise to dull pain numbness or pins and needles in the toes also...
HK
Sleven,
The pharmaceutical standards for PAD (peripheral arterial disease) are poorly elaborated compared with CAD (coronary artery disease). PAD therapies widely promoted and used by MD's include: aspirin (ASA), ASA plus (low dose) bid Xarelto, clopidogrel, statins, full-dose anticoagulation eg Coumadin, Xarelto, Eliquis etc.., other antiplatelet agents eg dipyridamole, BP-lowering Rx's eg amlodipine, peripheral vasodilators eg cilostazol.
Unfortunately, neither REDUCE-IT nor EVAPORATE addressed the PAD subgroup of CVD patients. The number of PAD patients in R-IT were insufficient even to mount a sub-set analysis of adequate power. The time IS ripe to do a PAD study in critical limb ischemia, because it is this subset that has the highest risk of CV death in the next 5 years-they generally lose their limbs and then their life. They are also heavily represented by smokers and diabetics, so they are a rich target for Vascepa.
HK
Zip, Tal, sts
Laurent
The irony here is whether you do prima facie first and secondary indicia second, one needs to (a) ensure that the prima facie evidence is actually true and (b) If you are going to discount secondary “ objective” indicia in favor of prima facie obviousness, then we had better be sure that that the “ unexpected results “ are not incorrectly disposed as obvious.
HK
Zip,
It's a good hypothesis if you see the 800 reps being divested as Merck would not need these for the US market
Agree with you marjac:
Invest 83838
The die is cast, come what may
Ratna
Proposal:
A few of us who take Vascepa should buy some of this, measure our baseline EPA levels, stop our Vascepa for 3 weeks, then start an algae-based EPA and remeasure our EPA levels after 4 weeks. We should then wash out for 2 weeks and restart our Vascepa for a further 4 weeks and remeasure levels. Any takers?
HK
Raf
If Judge Du is a judge of honor and integrity (which I believe to be the case) then there are only two questions she faces:
(1) Is the science EPADI proposes right?
(2) Was I misled?
Answering either of those questions in the affirmative mandates doing the right thing for the interests of the Nevada Court if no one else. Judge Du would understand that completely. This is no longer an ego issue, it is a paramount issue of judicial integrity and due process.
HK
Probably silent as cowards commit murder in silence and the dark.
Lets follow that reasoning Raf:
Mythical conversation; Act 1 scene 1
Judge Du: "Is this true, guys"
Amrn: "Er..Er..YES"
Judge Du:" Why didn't you point it out during trial?"
Amrn: "We kinda did..look at what Toth said about the Mori statistics. We thought it wasn't as important as showing you that EPA effects were uniquely distinguished in the TG>500mg/dl population. But you didn't seem to care much about that after hearing about that one theoretical maybe mythical patient in Hayashi"
Judge Du:" So what about Kurabayashi?"
Amrn: "Once again we thought you would be interested in the LDL part and that the patients had essentially the same TG levels as a normal population"
Judge Du: "But why did you ignore the ApoB. After all it was the basis of your patents being granted?"
Amrn: "Well, we thought Kurabayshi didn't show anything of relevance in the prior art to disproving our MARINE findings of EPA on ApoB. After all. wasn't it a negative study according to the authors? That is IF you assume the authors statistics were done right?"
Judge DU: "I see"
QED Quad erat demonstrandum
Dylan is to music what Shakespeare was to literature.
Classical Iambic Pentameter
Does everyone here miss the inescapable logic that mistake and fatal error leading to a prejudicial judgement is an absolute indication for the court itself to intervene someway, somehow, irrespective of the "standing" of either party? It is the Court ITSELF that has been defrauded. It cannot be that the judicial system has to rely on two incompetents to render due process. An innocent man cannot be sent to the gallows because the judge was misled by the prosecution as to the evidence for guilt or that the defence was so ill-prepared that it did not mention the exculpatory evidence against guilt. The court must rectify or we have no legal system worth having. We cannot have the blind leading the intellectually disabled.
HK
Capt-elegant summary and presentation-thank you
HK
They can still or may have communicated that to her in strict confidentiality
Iryo
Have you looked at Novasep’s algae sourced pure EPA capacity compared to Algysis?
What percentage of current capacity is algae sourced vs fish sourced?
Many thanks
HK
If I remember correctly Iryo NISSUI or nippon suisan kaisha has recently built significantly unused EPA production capacity
Appreciate that brother
Where is professor mitra he deserves our thank you also
Truly patients don’t know how hard their doctors have to work bureaucratically to get them their medication
You failed to say ( because you are humble) how much support you gave us to do it without which all would be impossible. So many people made it possible to try. I thank them all sincerely.
HK
Dear Ratna
It is my pleasure to have served our cause in some small manner. The truth is that the great moments of human evolution and accomplishments have come from small repetitive seemingly inconsequential actions of equally inconsequential people. It is equally the case that the pursuit of correct behavior truthful enterprise and ethical living is the only way forward for humanity. The Universal Truth is the oneness of all living things. To discover it we have to pursue what in the Hindu tradition is called the Sanatana Dharma. It is nothing more and nothing less than righteousness and the pursuit of Truth. I know you understand this. It compels the action we have taken as shareholders... whatever the outcome. The Truth is out at last. I pray all your health challenges resolve.
HK
We did our utmost, come what may.
Ataboy Ralphey
Send em my way
well said BTW--i hate that neanderthal attitude that only 'ologists can think!
HK
Great find Iryo,
I think it implies :
(1) That Amrn has Nissin Chemport (BASF) and KD Pharma
(2) CCSB is a Taiwanese option that Hikma retains for a v good reason--because I suspect if Amrn gets the Chinese market most Chinese API suppliers will simply defect to Amrn. The Indian API suppliers like DRL's sources have no ready source of quality API in India and the FDA has their eye on them after their NDMA contaminant shenanigans...
(3) Choking off API supply while keeping Hikma's and third-party payor's toes to the infringement fire while seeking definitive legal redress of infringement, while selling ?GIA in Europe and awaiting China and ROW is Amrn's strategy. Buy out is a lost dream.
On a side note, there is a French API supplier that utilizes an algae-based method for EPA production
What is your view?
HK
Apparently, only a cardiologist endocrinologist or lipidologist knows how to use this drug. This document has more IF's AND's & OR's than the average legal document! Clearly, United Health doesn't want too much Icosapent Ethyl flowing through the cardiovascular system of their clients.
HK
Yes indeed Iryo we will see what transpires May 1
I have few patients with UHC but on the East Coast and Midwest they are a large presence
Lem
I am in total (albeit cynical) agreement
Sad but true
HK
Iryo,
good point:
Presumably, step therapy works as follows:
(1) MD to UHC: " My post-MI diabetic patient with 3 stents and CAD/PAD already on generic omega 3 ethyl esters for the last year with TG=135, has had a recent stroke, his LDL is 70 mg/dl on max tolerated statin. Can my patient have Vascepa please for CV risk reduction?"
(2) UHC to MD: "No we don't believe in CV risk reduction or EPA after Dr Nissen's STRENGTH trial, Come back when TG is >150" then you can try a fibrate or if we have some generic icosapent ethyl in at a good PBM price we might let you have some...BTW who is this Dr Bhatt you keep quoting?
HK