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Amarin will not bring up cropped table non-controversy.
Would they be able to point out the cropped table ?
ACC comes to Hainan Boao LeCheng.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8488&pt=msg&mid=22035133
Viet Le put together good crew for study.
HIGHER DOCOSAHEXAENOIC ACID LEVELS LOWER THE PROTECTIVE IMPACT OF EICOSAPENTAENOIC ACID ON LONG-TERM MACE IN THOSE WITH AND WITHOUT ANGIOGRAPHIC CAD
Viet T. Le, PA-C (M.S. PAS) (working on DMSc)
Kirk U. Knowlton, MD
J. Brent Muhlestein, MD
Donald L. Lappe, MD
Benjamin D Horne, PhD, MStat, MPH
Jeffrey L. Anderson, MD
Stacey Knight, PhD, MStat
Raymond McCubrey, M.S. (Stat)
Jeramie Watrous, PhD, MS (Biological Chemistry)
Khoi Dao (Lab Assistant)
Mahan Najhawan, A.A. https://www.miracosta.edu/office-of-the-president/public-information-office/meet-our-students-staff-and-alumni/mahan-najhawan.html
Tami Bair, B.S.
John F. Carlquist, PhD (Microbiology/Immunology)
Madisyn Taylor (Lab Manager)
Mohit Jain, MD, PhD (Medicine, Pharmacology)
They likely used data and samples from:
IHCS Registry https://clinicaltrials.gov/ct2/show/NCT00406185
and probably also
Intermountain Enterprise Wide Data Warehouse (EDW)
https://medicine.utah.edu/surgery/research/research-cores/sparc/data-edw.php
HIGHER DHA LEVELS LOWER PROTECTIVE IMPACT OF EPA
Background:
Omega 3 polyunsaturated fatty acids (OM3-PUFA) are frequently used for cardiovascular prevention. While high dose eicosapentaenoic acid (EPA) reduces major adverse cardiovascular events (MACE)(JELIS, REDUCE-IT), combined EPA/docosahexaenoic acid (DHA) does not (STRENGTH, OMEMI). To clarify this, we compared the effects of EPA only, DHA only, and adjusted for one another on 10-y MACE.
Methods:
We used rapid throughput liquid chromatography-mass spectrometry to quantify plasma levels of EPA and DHA in 987 consenting patients (pts) undergoing angiography. 10-y MACE (all-cause death, myocardial infarction, stroke, heart failure hospitalization) was analyzed using Cox proportional hazard regression in 4 models: EPA only; DHA only; adjusted for one another, unadjusted/adjusted for severe CAD, COPD, and heart failure.
Results:
Age averaged 61.5 ± 12.15 y, 57% were male, 41% were obese, 42% had severe CAD, and 311 (31.5%) had a MACE. In the EPA only model, pts with the highest levels (Q4) were less likely to have a MACE (HR= 0.48 for Q4 vs Q1; 0.71 for Q2/Q3 vs Q1)(Figure). DHA alone was not associated with MACE. In both models EPA and DHA, EPA HRs decreased for high EPA, and pts with the lowest DHA levels were less likely to have a MACE.
Conclusion:
Higher levels of EPA but not DHA are associated with reductions in MACE. When combined with EPA, higher DHA blunts the benefit of EPA and increases MACE in the presence of low EPA, a novel finding. These findings may explain the discrepancy in clinical trial results.
https://www.abstractsonline.com/pp8/#!/9228/presentation/12635
Or maybe, just maybe ...
... they just promote the scientific sessions and don't tout the commercially sponsored sessions.
They purposefully didn't mention the presentation they will have at ACC21 in the PR. When companies do that kind of BS, that only means one thing. Buyout by year's end.
Don't get too excited Still ...
"Elevating the Standard" are regular Amarin-sponsored presentations
https://apha2021.pharmacist.com/fsPopup.asp?efp=UkFJRUJKQlkxMzczNQ&PresentationID=848120&rnd=0.7090379&mode=presinfo
https://www.bigmarker.com/kenes3/VASCEPA-icosapent-ethyl-Elevating-the-Standard-of-Care-Supported-By-Amarin
https://www.diabeteseducator.org/education/webinars/focus-on-persistent-cardiovascular-risk
https://www.cardiometabolichealth.org/boston-health-congress-2020-pme.html
But this looks like a real push:
https://meet.medpt.com/vascepa/webcast/Events.aspx
Notice to Amend the Supplemental Liquidity Deposit Requirements
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8459&pt=msg&mid=21983446
Thanks (thrice over) ggwpg.
Statement from a European Atherosclerosis Society Task Force
Practical guidance for combination lipid-modifying therapy in high- and very-high-risk patients: A statement from a European Atherosclerosis Society Task Force
2021 Apr 13;S0021-9150(21)00162-3. doi: 10.1016/j.atherosclerosis.2021.03.039. Online ahead of print.
Maurizio Averna 1,Maciej Banach 2,Eric Bruckert 3,Heinz Drexel 4,Michel Farnier 5,Dan Gaita 6,Paolo Magni 7,Winfried März 8,Luis Masana 9,Alberto Mello E Silva 10,Zeljko Reiner 11,Emilio Ros 12,Michal Vrablik 13,Alberto Zambon 14,Jose L Zamorano 15,Jane K Stock 16,Lale S Tokgözoglu 17,Alberico L Catapano 18
Affiliations
1 Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities, University of Palermo, Palermo, Italy.
2 Polish Mother's Memorial Hospital Research Institute (PMMHRI) in Lodz, Lodz, Poland.
3 Pitié-Salpêtrière Hospital and Sorbonne University, Cardio Metabolic Institute, Paris, France.
4 Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria; Private University of the Principality of Liechtenstein, Triesen, Liechtenstein; Drexel University College of Medicine, Philadelphia, PA, USA.
5 PEC2, EA 7460, University of Bourgogne Franche-Comté and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France.
6 Universitatea de Medicina si Farmacie Victor Babes, Institutul de Boli Cardiovasculare, Clinica de Recuperare Cardiovasculara, Timisoara, Romania.
7 Department of Pharmacological and Biomolecular Sciences, Universita' degli Studi di Milano, Milan, and IRCCS MultiMedica, Milan, Italy.
8 SYNLAB Academy, SYNLAB Holding Deutschland GmbH, and Medical Clinic V, Medical Faculty of Mannheim, University of Heidelberg, Germany; Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.
9 Vascular Medicine and Metabolism Unit, Research Unit on Lipids and Atherosclerosis, Sant Joan University Hospital, Universitat Rovira i Virgili, IISPV CIBERDEM, 43201, Reus, Spain.
10 Luz Saúde-Portugal; Sociedade Portuguesa de Aterosclerose, Lisbon, Portugal.
11 Department of Internal Diseases University Hospital Center Zagreb, School of Medicine, Zagreb University, Zagreb, Croatia.
12 Lipid Clinic, Endocrinology and Nutrition Service, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, 08036, Spain; CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Madrid, 28029, Spain.
13 Third Department of Internal Medicine, General University Hospital and First Faculty of Medicine, Charles University, U Nemocnice 1, 128 08, Prague 2, Czech Republic.
14 Department of Medicine - DIMED, University of Padua, Padova, and IRCCS MultiMedica, Milan, Italy.
15 Department of Cardiology, University Hospital Ramón y Cajal Carretera de Colmenar, Madrid, Spain.
16 European Atherosclerosis Society, Mässans Gata 10, SE-412 51, Gothenburg, Sweden.
17 Department of Cardiology, Hacettepe University Faculty of Medicine, Turkey.
18 Department of Pharmacological and Biomolecular Sciences, Universita' degli Studi di Milano, Milan, and IRCCS MultiMedica, Milan, Italy.
Abstract
Background and aims: This European Atherosclerosis Society (EAS) Task Force provides practical guidance for combination therapy for elevated low-density lipoprotein cholesterol (LDL-C) and/or triglycerides (TG) in high-risk and very-high-risk patients.
Methods: Evidence-based review.
Results: Statin-ezetimibe combination treatment is the first choice for managing elevated LDL-C and should be given upfront in very-high-risk patients with high LDL-C unlikely to reach goal with a statin, and in primary prevention familial hypercholesterolaemia patients. A proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor may be added if LDL-C levels remain high. In high and very-high-risk patients with mild to moderately elevated TG levels (>2.3 and < 5.6 mmol/L [>200 and < 500 mg/dL) on a statin, treatment with either a fibrate or high-dose omega-3 fatty acids (icosapent ethyl) may be considered, weighing the benefit versus risks. Combination with fenofibrate may be considered for both macro- and microvascular benefits in patients with type 2 diabetes mellitus.
Conclusions: This guidance aims to improve real-world use of guideline-recommended combination lipid modifying treatment.
Mighty suspicious indeed
English is not that blogger's first language, and whatever translation program he used is atrociously bad.
Curfman: Love him or hate him. Or both.
https://www.investorvillage.com/uploads/87669/files/Curfman-article-April-2021.pdf
We don't even know if fast-track requested ...
... but if it was, a decision whether to grant that status takes 6-8 weeks.
Yes, your one-year guesstimate seems reasonable.
I'd say maybe a little less. Amarin likely submitted "evidence submission" by April 15 (60 days from "invitation)
Evidence submission from the company
3.2.6 NICE invites the company to provide an evidence submission using a detailed submission template. The deadline for receipt of the evidence submission is 60 calendar days from invitation. After receiving this NICE sends it to the ERG for review.
3.2.7 The information needed for the evidence submission is derived from the approach NICE uses to evaluate the clinical and cost effectiveness of health technologies. This approach is outlined in NICE's guide to the methods of technology appraisal.
3.2.8 For fast track appraisals the evidence must be submitted in templates; the standard submission template or, if it is a cost-comparison case, in the cost-comparison template.
3.2.9 During the 60-day submission preparation stage there will be at least 1 opportunity for the company to discuss key issues with NICE and, if needed, the ERG. NICE will ask the company to provide an update on their submission before the meeting. This engagement will also allow companies to discuss potential regulatory developments during the appraisal and the potential inclusion and handling of commercial arrangement proposals. During the 60-day submission preparation stage companies can request additional engagement with NICE. Engagement will depend on availability of the NICE team at the time of request.
2.4.31 A technology can be considered for the fast track appraisal process if:
The company's base-case incremental cost-effectiveness ratio (ICER) is less than £10,000 per quality-adjusted life year (QALY) gained.
It is likely that the most plausible ICER is less than £20,000 per QALY gained, and it is highly unlikely that it is greater than £30,000 per QALY gained.
2.4.32 Judgements about the technology's suitability for the fast track appraisal process, considering the criteria outlined in section 2.4.31, will be based on:
the robustness of the clinical-effectiveness evidence and its generalisability to the population under consideration
the consistency of the submission with the scope of the appraisal
the consistency of approach to modelling with models accepted in previous appraisals in the same, or similar indications
the size of the population
the budget impact of implementing the technology
the uncertainties in the evidence and
the consequences of decision error.
If you don't like, why do you promote?
I really don’t like false narratives.
“ If NICE finally recommends the drug for use through the NHS, then NHS England is normally expected to fund the treatment within 90 days. ”. The site you mention linked shall be updated as that was the provisional schedule before approval. And NHS just approved!
UK Vazkepa cost-effectiveness appraisal scheduled for 1/5/22
https://www.nice.org.uk/guidance/indevelopment/gid-ta10736
Shouldn't take long for sales in U.K.
What is the process for securing reimbursement for a new pharmaceutical product?
As noted above, the NHS funds treatments in a number of different ways. This means there is no single pathway to securing NHS reimbursement for a new product. Nonetheless, NICE is often considered the gatekeeper to reimbursement, because a positive recommendation for a product or treatment from NICE obliges the NHS to make funding available for it, usually within three months of the recommendation.
https://www.cov.com/-/media/files/corporate/publications/2020/08/united-kingdom.pdf
NICE’s Standard Assessment Methodology
For most conventional products, NICE will issue a positive recommendation if it assesses a product to have an ICER, usually against an existing reference, of less than £20,000. NICE may apply its discretion to recommend technologies with ICERs between £20,000 and £30,000, where justified on certain grounds, such as the innovative nature of a drug.
U.S. ICER issues positive recommendation for Vascepa
https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-additive-cardiovascular-disease-therapies/
From Reuters - Linked-In
Fantastic to hear from Amarin Corporation's CEO-Elect Karim MIKHAIL about the exciting commercial function they've built across Europe! What a great way to kick off Pharma Customer Engagement Europe!
Mechanistic Insights from REDUCE-IT STRENGTHen the Case
Against Triglyceride Lowering as a Strategy for Cardiovascular Disease Risk Reduction
https://www.investorvillage.com/uploads/87669/files/Mason-pub.pdf
Thanks sleven.
EU Product Information for Vazkepa
https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-infomartion_en.pdf
EU EPAR - Medicine Overview for Vazkepa
https://www.ema.europa.eu/en/documents/overview/vazkepa-epar-medicine-overview_en.pdf
EU Risk Management Plan for Vazkepa
https://www.ema.europa.eu/en/documents/rmp-summary/vazkepa-epar-risk-management-plan-summary_en.pdf
What's FUD Louie - Facts U Detest?
I said:
Potential reasons for delay in acceptance of application:
1) judge too busy to affix signature
2) judge sees no reason to approve if there will be no hearings
3) judge doesn't think requirements of ABA model rule are met
Judge Du instructed that the pro hac vice will be decided at the time of the Motion to Intervene.
Has pro hac vice application even been approved?
Marjac - is there a date that you are planning to contact the court, if the court doesn't address your 24/60 filing by?
Does Thero have a Garden Leave clause
... like Mikhail
Garden Leave
The Company may require the Executive to take garden leave (“Garden Leave”) and not to attend at work and/or not to undertake all or any of his duties hereunder during all or any part of any period of notice (whether given by the Executive or the Company) PROVIDED ALWAYS that during any period of Garden Leave the Executive will continue to receive his salary and contractual benefits and all obligations and entitlements under this Agreement continue to apply and the Executive otherwise remains bound by his employment obligations to the Company (including the obligation of exclusive service to the Company). If the Executive is required to take Garden Leave the Company may require the Executive:
(a) not to attend at his place of work or any of the Company’s other premises;
(b) not to carry out all or part of his duties during the notice period;
(c) to return to the Company all documents and other materials (including Copies) belonging to the Company;
(d) not without the prior written permission of the Company contact or attempt to contact any of the Company’s clients, customers, suppliers, agents, professional advisers, brokers, or bankers or any of the Company’s employees; and
(e) engage in, or be concerned with, or provide services to, (whether as an employee, director, agent, partner, consultant or otherwise) any other business until the date that employment terminates.
Cuz, she gonna get beat with ugly stick.
Du got the best opportunity to reverse her decision acting on marjac's suit. Things can easily get very ugly for her otherwise, imo.
Good work STS
Quote:
something not kosher about LTRO pls see post #319864, posted back in January to one of your replies. Watch out for imposters. China news was released just a few days ago.
??? That Hainan news *was* released in China back in Jan - I don't see what you're getting at - nothing "new" was announced a few days ago - AMRN revealed the Hainan news in a PR on 2/25 but didn't go into any detail:
JAMA - Comment and Response
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8329&pt=msg&mid=21880672
Wow, you are fact-confused
Quote:
The legend is from the Kurabayashi tables in Appendix F in Rule 60 motion but is small and blurry there.
Yes the legend was not reproduce for the courts because Hikma’s attorneys didn’t want Judge Du to squint at the blurred copy.
Wow, there's a revelation
The cropped table was just a necessity to save word count
Maybe they can put you on the stand
That's not a mistake, it's fraudulent testimony by Heinecke.
Not for me to answer, but
Which part(s) is(are) the important one?
Keep asking, or just view below.
Where is the legend on the original doc that is missing on Du's docs?
8 – I thought original Rule 24 motion
… was very good without necessitating the presence of fraud. Indeed, the only part that strained credulity is the small section that indicates he is bringing the action to protect the integrity of the court (from fraud). But it was good. And I see no reason to suddenly bring more of a focus on fraud as was suggested this morning. Hikma’s case against Rule 24 is so weak it starts off sounding like a laches defense. And ends up making a weak Rule 60 rationale for why there is no standing. All of the Hikma arguments made against intervention are rebuttable by just sticking to the arguments originally made. And emphasizing mistake.
M - I doubt you believe she did that
why you think "fish oil" and Vascepa are interchangeable? Du's conflation of that very point belies her ruling of obviousness.
Proof is in da pudding
Manipulating the evidence to make it appear to say something it does not actually say is always material as evidence of at least unfair, inequitable conduct
Doubling down on fraud …
… would be like doubling down on judicial misconduct. Self-defeating. Let’s talk about the judicial misconduct complaint. Completely spiteful nonsense. Read the complaint. Read the article that the complaint is based upon. Somebody please tell me where the beef is. Like throwing dishes against the wall, maybe it made some feel good in the moment but no positive value after that. Any attorney filing such an ethics charge should be embarrassed, as should the posters supporting that spite. At least thirty-two posters sung praises for filing that complaint; others supported it beforehand; others were conspicuously silent. One had the good sense to find the idea laughable in advance. Like the thrown dishes, this was never a good idea even standing alone. Now, how many of those supporters, having read how Hikma has reminded the judge that this is the same attorney who reported her to the State’s regulatory authority for using the phrase “fish oil,” still think that was a stroke of brilliance to file that complaint.
But that is past. And now it appears the legal strategy is to double down on accusations of fraud. There is no credible allegation of fraud no matter how many times that word is uttered in the motions (61 times, versus 0 mentions of negligence). There is no credible allegation of fraud no matter how many times use of the word is cheered on by aggrieved shareholders’ postings. So, if Hikma’s lawyers have taken umbrage over the unsupported allegations, there may be good reason. And this morning we learn that in a Lou Reed-induced moment of brilliance, the legal strategy is to use fraud in the Motion 24 justification for standing. That would be particularly easy for the Court to dismiss, and allow complete avoidance of the real issue of mistake the Court made. Just out of curiosity, if there were such blatant examples of fraud in the judgment and trial transcript, then why two months out were you focused on the judge using the term “fish oil.” Not a post mentioning fraud, not a filing. But when Curfman points out mistake, suddenly you “see” all this “fraud” that was there all along for your esteemed viewing. Either the fraud existed all along and went unnoticed for months, or has been conjured up from legitimate and serious questions of mistake. In making the motions so much about fraud, you undermine that legitimate issue of mistake. So, if this is about shareholders rather than petty grievances against defendants and a judge that ruled against Amarin, then please put away the fake outrage and put forth credible arguments. The court will not see this as a negotiation where alleging fraud is an opening gambit. Otherwise, perhaps the next motion filed may be a Rule 11.
Might be time ...
... to get out the Tiki torches and head to Reno.
Du- A two bit judge in a seven cent court.
Maybe just reminding Du
.... of their belief that the filer of the Du Nevada Bar complaint, and the current motions, showed all the ethics of a fake Yelp review combined with a formal complaint to the Health Inspector claiming a restaurant has cockroaches because they wouldn’t serve your friend without ID a drink. Because after all, Du did commit the grievous offense of mentioning “fish oil” in a trade publication.
Also, bringing up the judicial misconduct filing, they are implying Judge Du can be swayed by personal animus,
Nice gg - ain't gonna be Door Number 2
... because it is not in accord "with the practices of this Court" and federal circuit never "held oral argument" to my knowledge.
"Whether the Federal Circuit properly issued a
Federal Circuit Rule 36 Affirmance, as
authorized by Federal Rule of Appellate
Procedure 36, where an opinion would add
nothing of precedential value in future cases?"
and/or
"Whether the Federal Circuit violated due process
when, in accord with the practices of this Court and
every other Circuit, and after two prior written
opinions on the same patent claim, it received full
briefing on petitioner’s appeal, held oral argument,
and then summarily affirmed the District Court’s
decision on the ground that the decision “ha[d] been
entered without an error of law.” Fed. Cir. R. 36(e). "