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Examiner - still no decision.
"Lettru
Was it denied or still no decision ?"
Supreme Court cert reviews picking up
Two granted; 200+ denied at last Friday's conference. Amarin didn't make the list.
https://www.supremecourt.gov/orders/courtorders/032221zor_l5gm.pdf
Looks like a standard RCR presentation to me
The NIH requires all scientists who receive funds to do 'Responsible Conduct of Research' training every year or so. The topics are plagiarism, falsification, and fabrication. The training is done mostly on-line these days but back in earlier days, institutions had someone give presentations to groups. I was the one who gave the IRB and HIPAA presentations before they went on line, and also the one that made sure NIH-funded researchers had documented their RCR training. So, not only did Heinecke develop these RCR slides, but he has taken the training upwards multiple times over the years.
http://www.rcr.gatech.edu/research-misconduct
Study, Not sure I would go that far.
But if you put Heinecke on the stand, he could not say he never thought about issues of data misrepresentation or removing data from a figure. Indeed, he would have to admit that it raises the issue of fraud.
Jay Heinecke - Responsible Conduct of Research presentation
Slide 14 asks the question Is it fraud to remove less convincing data from a figure?
https://www.investorvillage.com/uploads/87669/files/Heinecke-RCR-presentation.pdf
Somebody pull PDF from link and post here
I think it is complete and without redundancies
https://www.investorvillage.com/uploads/87669/files/Motions-24-60.pdf
Anybody got a phone number for PJ or Squi?
We gotta find someone with Brett Kavanaugh's private phone number. It is very possible that the Supreme Court justices are in their Friday afternoon conference RIGHT NOW reviewing certiorari applications. They did not meet last Friday for whatever reason. If they are meeting now, there is a good chance that the Amarin petition is on their agenda. Yesterday was deadline for responses and both Hikma and Dr. Reddy filed paperwork indicating they decided to waive a response. Thus, the law clerks that prepare the files for the Friday conferences, had everything including the three amicus briefs supporting Amarin, for weeks now while waiting for the Dr. Reddy waiver to come in this week. Odds are very much against any plaintiff that seeks certiorari, so people should assume it will not be granted in our case. If it was on today's list, we should know the decision made by late Monday. The last Friday conference yielded 1 grant of cert and 71 denials. Fingers tightly crossed.
As someone with not unrealistically high expectations,
I thank you marjac, HK, etc. for all the time and energies expended on this effort. I have no doubt you put together a high quality product. Not unlike Vascepa.
I'm sure they're willing to do that
.. and look under that pile of shit in your backyard, I think they put a pony there.
"Hikma should pay all the billions we lost in the market cap. I want my money lost on my AMRN holdings including that in the options."
thanks for your contributions luvbio ...
to racial hatred
Hey, who asked for your opinion.
https://www.supremecourt.gov/DocketPDF/20/20-1119/172050/20210316132141414_20210316-132055-95752975-00000629.pdf
Those decisions are disclosed only on Mondays.
"A decision by S.Ct. on cert petition could also happen any time next week"
Should be a PR on this before long.
Embargoed until 4 a.m. CT/5 a.m. ET Thursday, March 11, 2021
DALLAS, March 11, 2021 — Taking the triglyceride-lowering medication icosapent ethyl cut the risk of stroke by an additional 36% in people at increased risk of cardiovascular disease who already have their bad cholesterol levels under control using statin medications, according to preliminary research to be presented at the American Stroke Association’s International Stroke Conference 2021. The virtual meeting is March 17-19, 2021 and is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.
“Icosapent ethyl is a new way to further reduce the risk of stroke in patients with atherosclerosis or who are at high risk of stroke, who have elevated triglyceride levels and are already taking statins,” said Deepak L. Bhatt, M.D., M.P.H., lead author of the study and executive director of interventional cardiovascular programs at the Brigham and Women’s Hospital Heart & Vascular Center in Boston.
https://newsroom.heart.org/news/adding-triglyceride-lowering-omega-3-based-medication-to-statins-may-lower-stroke-risk
Yea, yea, yea ,,, raf, raf, raf
It was a very good clip. And as was pointed out by raf, Ms. Chinn deserves much credit.
If you haven't already, consider sending her a SHORT note indicating you saw and liked her Omega-3 story (if you did).
schinn@abc4.com
include her boss and GM/VP Nexstar Broadcasting Group
Richard Doutre'Jones <rdj@abc4.com>
Thanks, as always, for posting script numbers raf.
A little about Aimed Alliance (amicus submitter)
Mission
Aimed Alliance is a 501(c)(3) not-for-profit health policy organization. The mission of Aimed Alliance is to protect and enhance the rights of health care consumers and providers.
Vision
The vision of Aimed Alliance is a society in which consumers, in consultation with their health care providers and loved ones, can make informed and individually appropriate decisions about their health care, and those decisions are not overridden by third parties.
Beliefs
We believe that Americans should value their health care and prioritize it as consumers.
We believe that health care industry stakeholders should place the health and safety of patients above all other considerations.
We believe that the costs of health care services should be reasonable and transparent.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8249&pt=msg&mid=21771640
Lumoxiti is having orphan status re-reviewed.
That is the hold up.
That's not what I am seeing.
"Hedgie
: Last 5 days short percent 34.87%
Last 10 days short percent 36.07%
Last 20 days short percent 34.70%
Last 50 days short percent 34.82%"
https://fintel.io/ss/us/amrn
Vascepa: Elevating the Standard of Care
March 12th - American Pharmacists Association (APha) Meeting
https://apha2021.pharmacist.com/searchGlobal.asp
Supreme Court could take up Amarin's case
The Supreme's denied cert in the Zup v Nash manufacturing case, and that was just two years ago, with a different Court make-up. This too was an obviousness case, with the subject matter being a recreational water board. The Court often waits for an appropriate case before deciding to review, and maybe a glorified boogie board was deemed not to be the right case. Plenty of Amici briefs on that one, including US Inventor, Inc.
So, the last time the Court took an obviousness case may well have been Carnegie Steel v Cambria Iron in 1902. In that case the court said
"It is true the Jones patent is a simple one, and in the light of present experience it seems strange that none of the expert steel makers, who approach so near the consummation of their desires, should have failed to take the final step which was needed to convert their experiments into an assured success. This, however, is but the common history of important inventions, the simplicity of which seems to the ordinary observer to preclude the possibility of their involving an exercise of the inventive faculty. The very fact that the attempt which had been made to secure a uniformity of product, seems to have been abandoned after the Jones invention came into popular notice, is strong evidence tending to show that this patent contains something which was of great value to the manufacturers of steel, and which entitled Jones to the reward due to a successful inventor."
One hundred nineteen years later, the Court may be ready to lay down the law on obviousness once again.
https://www.ipwatchdog.com/2019/01/23/supreme-court-grant-cert-zup-correct-obviousness-doctrine/id=105549/
Here you go postes
This Dr. worked wonders on his last client so might be just what you need.
https://www.investorvillage.com/smbd.asp?mb=633&mn=318666&pt=msg&mid=21750251
postes - two words 4U: Lax & Neville
Whine to them, won't you. Or I can provide you the name of a good shrink.
https://www.newyorksecuritieslawyerblog.com/amarin-a-highly-risky-speculative-biotech-stock-sold-to-investors/
I don't think FTC complaint going anywhere
Hikma provided info back in October. Amarin would have been contacted by now if the complaint had legs. Given that Amarin didn't include anything in their 10K, I'd say it is a dead letter. Just Hikma being spiteful because they can't get supply they don't need if they are only supplying prescriptions for which they had FDA approval.
Sleven - can't be sure about this
... but Hikma was probably trying to buy up API long before launch and found that Amarin had the bulk of the supply committed to them. Hello ... FTC, I'd like to make a complaint.
"I didn't think Hikma launched a product until November 5th. Who were we competing against in October?"
Might be more evidence of Hikma dishonesty
If indeed, Hikma dropped a dime on Amarin to the FTC and then issued a statement via the web suggesting they were just minding their own business when the FTC approached them for information about Amarin's unfair trade practices, then that tactic should be used to show various courts the dishonest mindset that Amarin has been dealing with.
"In October 2020, Hikma received a voluntary request for information from the US Federal Trade Commission requesting information related to its investigation into whether Amarin Pharma, Inc. has engaged in, or is engaging in, anticompetitive practices or unfair methods of competition relating to the drug Vascepa®."
Hikma waiver to submit cert response at USSC
https://www.investorvillage.com/uploads/87669/files/Hikma-waiver-USSC.pdf
HIKMA owns up to API availability problem
London, 25 February 2021 - Hikma Pharmaceuticals PLC ('Hikma' or 'Group'), the multinational pharmaceutical company, today reports its preliminary audited results for the year ended 31 December 2020.
During the year, we demonstrated our ability to challenge patents and obtain approvals for complex products. We received US FDA approval for icosapent ethyl capsules in May and following a successful court ruling, we launched the product in November. Our ability to supply the market with this product is constrained at the moment due to limited availability of the active pharmaceutical ingredient and we are working hard to improve supply quantities over the course of 2021.
In October 2020, Hikma received a voluntary request for information from the US Federal Trade Commission requesting information related to its investigation into whether Amarin Pharma, Inc. has engaged in, or is engaging in, anticompetitive practices or unfair methods of competition relating to the drug Vascepa®. In October 2020, Hikma also received a subpoena duces tecum from the State of New York, Office of the Attorney General, seeking information relevant and material to an investigation related to Amarin Pharma, Inc. Hikma is cooperating with all such demands.
https://www.investegate.co.uk/article.aspx?id=202102250700072716Q
My favorite moment from GSK hearing
Judge is questioning Teva lawyer and he is indicating that the infringing press release might not have even been on Teva's website but instead limited to presence in the archives.
Judge says (not verbatim) I decided to google and the first thing that popped up was that "damn" press release. So, it is not like that information was buried in a shoe box in the archives in Teva's basement.
Spain starts working Therapeutic Positioning Report for Vazkepa
This document provides a summary of the topics discussed at the meeting of the REvalMed SNS Coordinating Group (GC), on February 4, held by teleconference.
At the meeting it was agreed to start working on the Therapeutic Positioning Reports (IPT) of the following medicines with a positive opinion from the CHMP at the January 2021 meeting:
Vazkepa® (icosapent ethyl): from Amarin Pharmaceuticals Ireland Limited, indicated for the reduction of the risk of cardiovascular events in adults taking statins, with a high risk of cardiovascular events, high triglycerides (> 150 mg / dL) and
- established CV disease
- diabetes and one other CV risk factor
https://www.aemps.gob.es/informa/informes-de-posicionamiento-terapeutico/reuniones-gc-revalmed-sns/2021-7/informacion-de-la-reunion-del-gc-de-la-revalmed-sns-celebrada-el-4-de-febrero-de-2021/
Maybe Texas could practice adequately supplying one state
,,, before you commit them to meeting the energy needs of the nation. Start with, I don't know, maybe Texas for example.
CAPT Beer "FUCK this Green Energy shit! Texas could supply the entire nation with its dependable fossil-fuels."
Bhatt: potential future uses of icosapent ethyl
Abstract : The REDUCE-IT trial demonstrated that icosapent ethyl, an ethyl ester of eicosapentaenoic acid (EPA), reduced cardiovascular events in an at-risk population by a substantial degree. While the cardiovascular protective properties of this compound are now proven, several other potential uses are being actively explored in clinical studies. These areas of investigation include cancer, inflammatory bowel disease, infections, Alzheimer's disease, dementia, and depression. The next decade promises to deepen our understanding of the beneficial effects that EPA may offer beyond cardiovascular risk reduction.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8210&pt=msg&mid=21713170
It is very good
and can be viewed with Amazon Prime.
ABC4 apology
EDITOR’S NOTE: Upon original publication, an image of a pill was used with the understanding it was a picture of a fish-oil capsule. Unfortunately, the photo had a brand name printed on the pill not associated with the story in any way. As soon as this mistake was noticed, the image was immediately changed. ABC4 apologizes for any confusion.
https://www.abc4.com/health-2/prescription-fish-oil-doesnt-provide-heart-benefits/
Trademark dilution
Trademark Dilution: Trademark dilution happens when you use a famous trademark in a way that is likely to weaken its capacity to identify the famous trademark owner's goods or services or to tarnish the reputation of the mark. The trademark owner need not show that you created consumer confusion, and dilution may occur even if your goods or services are completely different from the trademark owner's. Because of dilution law, it's probably not a good idea to call a blog "Kodak News" or "McDonald's Blog," unless it is actually about Kodak or McDonald's.
https://www.dmlp.org/legal-guide/trademark
These dentists were interested in Omega3 and inflammation
Published:February 05, 2021
Abstract
Objectives
The aim of this study was to determine the effect of omega-3 on the painful symptomatology of osteoarthritis (OA) in synovial joints,
Methods
Electronic/manual search was conducted (2004-2019). Using pain as primary outcome and stiffness/function and swelling as secondary outcomes, based on PRISMA criteria, CONSORT reporting quality and Cochrane/RoB-2 risk of bias assessment. Data was processed statistically by RevMan v5.2.
Results
Six randomized clinical trials (RCTs) were involved. The study population included 454 subjects with OA. In four studies the pain of the intervention group presented significantly favorable results compared with control (MD=22.89 CI=3.37-42.42) It was not possible to establish the effective anti-inflammatory dose. For stiffness/function and inflammation the number of studies was low (n=2).The evidence and degree of recommendation was 2B. The RCTs presented high clinical and methodological variability.
Conclusion
Omega-3 presents significant reduction of painful symptoms in patients suffering from OA in their synovial joints. However, the limited number of studies, the diversity of doses, intervention periods, baseline characteristics of patients, and asymmetry in reporting bias, combined with the heterogeneity in the combined effect of the studies, determined low quality evidence that did not allow offering a clinical guide.
https://www.oooojournal.net/article/S2212-4403(21)00067-5/fulltext
But if I looked you in the eye
... and said, it is clear that Amarin has went up three dollars since Christmas would you attribute that statement to some political ideology?
Somethings are clear, and provable. Generalizations rarely are.
Great Monkman, provide your evidence for disproportionate use.
Then there's the other 50%
who are not smart enough to understand the concept of free and fair elections on their own so wouldn't have the ability to make a rational decision as to why Vascepa is in their best interest.
That's a safe bet now.
(And they did tell us that there has only been 8% positive in PREPARE-IT-1)
A humbler man might admit you had a point.