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I go back to JT saying "I like our patents". I also go to the majority/all but 1 of the analyst thinking this will get settled. Part of the concern I am sure is without patent understanding this just seems like a black hole, I get it. Either you trust them on this or you don't. I trust him. He is conservative and is not going to say "I like our patents' if he thinks there is a real risk here. Also, TEVA settled and they wouldn't have settled if there was a chance they could win.
Every good drug has patent litigation. If the drug was crap you wouldn't see companies try and market a generic. It is part of the risk of biotech. This AMRN litigation has nothing to do with the AMGN litigation. AMGN litigation has to do with other marketed drugs. That is not the case with the current case. It is an overblown fear.
I agree, if this settles we could see an explosion in PPS. I think many shorts are still riding on the Faux fact that the patents for Icosapent ethyl will not stand up.
You can follow this thread to see if it helps you.
Does the fact that the ONLY subgroup to see no benefit from icosapent ethyl in REDUCE-IT was the low intensity statin group lend credence to the concern that mineral oil in the placebo interfering with statin uptake and driving the positive CVD results? $AMRN pic.twitter.com/wqphWUdro8
— SirtSix (@SirtSix) August 29, 2019
So now since it is going in your favor it is okay to cherrypick a small subset of data from a larger trial?
The docket says response due 8/30 for the 8/8 ad 8/9 filings.
He said yesterday, we are going to have an AdCom in November and the PR said on Monday that the AdCom is scheduled. The PR did not say tentatively scheduled, it said scheduled.
If the delay in AdCom is due to poor scheduling on the FDA's part and not due in part to something Amarin did, you will not see a delay in PDUFA date. The FDA will just fail to meet their obligation. Their goal is to make a decision on 90% of their applications. Jt just told us yesterday the AdCom is in November.
You can heck to see what pharmacy benefits administrator that particular BCBS plan uses. Once you know what PBA the company uses you can check their formulary. Kaiser manages costs/care which is not always best for your health. BCBS leaves you choices of doctors/hospital and treatments. Yes, you may pay a little more out of pocket but you can get the treatment you want/need.
Just a thought, if it is going to be an ongoing issue, why don't you'll just redraft.
At the top of the article, it states they have been battling for years. The other companies have other PCSK9 drugs with their own patents. No one is asserting anything of the sort with $AMRN patents. These drugs have nothing to do with AMRN. This case has nothing similar to anything AMRN has going on. Calm down.
Everyone should spend an hour watching this. It will eliminate any fears regarding Vascepa. The Q&A at the end is especially eye opening.
https://reachmd.com/clinical-practice/pulmonary-medicine/clinicians-live-new-opportunities-reduce-residual-risk-beyond-statin-therapy/10911/
There is a 90% goal in the non-program group as well.
That would be quite a stretch.
Amarin should be receiving some clarification this week if the Nov 14th date holds.
For open advisory committee meetings that involve sponsor-prepared briefing materials, approximately 55 business days before the meeting is scheduled to occur, FDA intends to notify a sponsor that an advisory committee will consider an issue that is directly relevant to the sponsor. We will explain the meeting’s focus to the sponsor and also may advise the sponsor about the information it may wish to include in its briefing materials. To facilitate the review and eventual posting of sponsor-prepared briefing materials, we strongly recommend that sponsors submit both paper and electronic versions of their materials. Sponsors should consult the appropriate FDA component about compatible electronic formats and consult the Designated Federal Official6 for a given meeting to determine the appropriate number of paper copies.7
It should be published well before that, but that is the regulation.
When are meetings announced to the public?
FDA is required to publish announcements of advisory committee meetings at least 15 calendar days before a meeting date in the Federal Register (41 CFR sec 102-3.150). Once a meeting is published in the Federal Register, it is posted on FDA's advisory committee meeting calendar, which can be found on the Advisory Committee Calendar page.
FYI, Dr Bhatt gets more influential.
Braunwald’s Heart Disease Welcomes Two New Editors
8/27/19
Paris, August 31, 2019 – Elsevier, a global information analytics business specializing in science and health, is pleased to welcome Deepak L. Bhatt, M.D., M.P.H., and Scott D. Solomon, M.D., to the prestigious Braunwald’s Heart Disease Editorial team, as planning for the 12th edition begins.
Trusted by generations of cardiologists for the latest, most reliable guidance in the field, Braunwald’s Heart Disease continues to be one of the leading sources of information on rapidly changing clinical science, clinical and translational research, and evidence-based medicine.
The editors salute Dr. Douglas Zipes who contributed to Braunwald’s Heart Disease since the second edition and served as editor-in-chief for two editions. His energy, expertise and experience contributed enormously to the success of this book and its companions. As Prof. Zipes leaves the editorial group to pursue other interests, Dr. Gordon Tomaselli now leads the electrophysiology and arrhythmia sections of Heart Disease.
Drs. Bhatt and Solomon will join Braunwald’s Heart Disease as new co-editors for the 12th Edition. They both have made major contributions to contemporary cardiovascular medicine, and each has several areas of expertise that they bring to the editorial team.
“We are fortunate to have such talented, accomplished and experienced clinician-investigators and teachers join us. Their contributions will help us continue the tradition of excellence established by Dr. Braunwald and assure the high quality of the 12th edition and its usefulness to practitioners and trainees for learning and as the cardiovascular reference for their practices,” said Prof. Peter Libby, who will take the role as lead editor of the 12th edition.
Dr. Bhatt, Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center, and Professor of Medicine, Harvard Medical School, has authored over 1250 publications and is the editor of Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease.
“What an incredible honor and joy it is to be joining this all-star team of Braunwald’s Heart Disease Editors,” Dr. Bhatt said.
Dr. Solomon is The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School and Senior Physician at Brigham and Women’s Hospital. Dr. Solomon has authored more than 600 peer-reviewed articles, reviews and editorials, three textbooks of cardiac imaging, including Essential Echocardiography, A Companion to Braunwald’s Heart Disease (2018), and the Echocardiography sections for the 10th and 11th edition of Braunwald’s Heart Disease.
“It is a distinct honor to join this extraordinary team on what is arguably the premiere educational source in cardiovascular medicine,” said Dr. Solomon.
Editors of Braunwald’s Heart Disease, 12th edition, also include:
Peter Libby, M.D., Senior Physician, Brigham and Women’s Hospital, Mallinckrodt Professor of Medicine, Harvard Medical School;
Robert Bonow, M.D., Max and Lilly Goldberg Distinguished Professor of Cardiology, Northwestern University Feinberg School of Medicine;
Douglas L. Mann, M.D., Chief, Cardiovascular Division, Lewin Chair and Professor of Medicine, Washington University School of Medicine, Cardiologist-in-Chief, Barnes Jewish Hospital;
Gordon F. Tomaselli, M.D., The Marilyn & Stanley M. Katz Dean, The Albert Einstein College of Medicine, Executive Vice President and Chief Academic Officer, Montefiore Medicine.
Braunwald’s Heart Disease, 11th edition, is available to purchase in both single volume and two-volume formats. The print copy of the book includes the enhanced digital version e-book, also available via elsevierhealth.com for purchase by itself, and at industry events and conferences, including ESC 2019.
About Elsevier
Elsevier is a global information analytics business that helps scientists and clinicians to find new answers, reshape human knowledge, and tackle the most urgent human crises. For 140 years, we have partnered with the research world to curate and verify scientific knowledge. Today, we’re committed to bringing that rigor to a new generation of platforms. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, 39,000 e-book titles and many iconic reference works, including Gray’s Anatomy. Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. www.elsevier.com
Yes, I don't believe it is a viable idea in the US. I think it was a very small trial in a third world country.
i think that is the idea of this pill. All in one but Vascepa could easily be prescribed on top of this for the additional residual risk reduction.
The “polypill” includes a statin, aspirin and two blood pressure-lowering medications in one.
There is nothing in regulations about the FDA needing to know MOA before approval. There is plenty of evidence readily available that the MOA is a combination of all of the things listed. There is no way that any one thing is going to get pinpointed as the only MOA.
EVAPORATE is not even a Amarin sponsored trial. It will just help with MOA but it has nothing to do with safety or efficacy. The idea that anyone would need this for approval does not make any sense except to those who want to create uncertainty.
Are you saying that you heard from Amarin that they have not heard anything from the FDA?
"Does the FDA agree that this is an unmet need? " How could they not when cardiovascular disease is still the number 1 killer. Do people die when taking statins, yes. It is an unmet medical need.
They would PR it, not send it to FDA. If you send unsolicited data to the FDA you risk starting the clock over again.
My thoughts are that If the ruling goes in Amarin's favor we could see a settlement pretty quick.
Looks to me like they do not need ICER or Evaporate for massive label expansion.
There was nothing negative in those documents for the partial summary judgement. I just think it is related to the delay
That is not the only way to gt rid of short position, that is ridiculous.
Short interest up 15 Million shares, yes, 15 million shares. https://www.nasdaq.com/symbol/amrn/short-interest
It wasn't a press release, it was during their (HLS) last earnings call.
HLS has stated they anticipate a late November 2019 approval and a February 2020 launch.
The Judge is suppose to rule on Amarin's request for a partial summary judgement against Dr Reddy/Hikma by this Friday.
Dr. Reddy/Hikma expert witnesses failed to address majority of reasons to invalidate patents It is pretty common at this stage of the proceedings that expert witnesses would address all of these areas and leave options open if they really intent to go to trial. If the judge does agree with the partial summary judgement, this is likely to be a very possible catalyst as Dr. Reddy/Hikma will really not have a case to proceed forward. We would likely see a settlement soon after.
I think It is a relief. There was so much FUD out there about the review being suspended it is good to see that it is continuing. I like the fact that Canada approval may come before FDA, making the FDA look bad.
The process can include both. With this large patient population, it is not one or the other.
I think they are off base on having two different approvals but label wording does get negotiated.
Once again, you can't appeal a rescindment of a priority review when there is no such thing and when there hasn't been one.
I think the type of priority review vouchers that get sold are for neglected tropical diseases or for a rare pediatric disease
I have never seen a priority review rescinded. The FDA just fails to meet the priority review deadline.
With like Breakthrough designation they do rescind those because the drug during the clinical or review process may no longer be considered a breakthrough because of problems with the drug or because something else has come onto the market. As far as i know priority reviews do not get rescinded.
It is a credibility thing at this point. You brought up this program review and how Amarin was not pursuing it, and now you are saying it is irrelevant. So is this just something you pursued for the message board to make it appear Amarin CEO was incompetent?
At the same time you are now saying that "The agency has threatened to take action and retract/rescind Priority Review on a whim from Office of the Commissioner." Where did this happen? Where is the proof? The FDA still needs to meet their goals as this drug did receive priority review notification.