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      6. Amarin Corp PLC (AMRN)

      7. Amarin Corp PLC (AMRN) News

      Amarin Corp PLC

      Amarin Corp PLC (AMRN)

      NASDAQ
      0.6058
      0.0127
      (2.14%)
      Closed October 05 4:00PM
      Delayed by 15 minutes
      0.605
      -0.0008
      (-0.13%)
      After Hours: 6:55PM
      Delayed by 15 minutes

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      AMRN News

      Official News Only

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      August 05 2024
      AMRN (2.14%)

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      August 01 2024
      AMRN (2.14%)

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      August 01 2024
      AMRN (2.14%)

      Form 8-K - Current report
      Edgar (US Regulatory)
      July 31 2024
      AMRN (2.14%)

      Form 10-Q - Quarterly report [Sections 13 or 15(d)]
      Edgar (US Regulatory)
      July 31 2024
      AMRN (2.14%)

      Form 8-K - Current report
      Edgar (US Regulatory)
      July 29 2024
      AMRN (2.14%)

      Form 8-K - Current report
      Edgar (US Regulatory)
      June 04 2024
      AMRN (2.14%)

      AMRN Discussion

      View Posts
      CaptBeer CaptBeer 29 minutes ago
      $AMRN off-topic, but my grandson is stationed at Ft Campbell, he’s a crew chief on a CH-47 Chinook helicopter. They’re on there way to NC to provide aid to those forks. Proud Grandpa!
      👍️ 1
      Number sleven Number sleven 4 hours ago
      MA52TA, Thanks. Maybe in the next few days.i went to the "Gazette" home page and did a search. Four publications came up from 2021-2023.
      Sleven,
      👍️ 1
      MA52TA MA52TA 4 hours ago
      If you look at the publication dates, in the "Official Gazette", (on the left), 1-2-3-4-5-October. Every day they publish a part of it.
      Maybe next week we'll see what we're looking for.
      👍️0
      Number sleven Number sleven 5 hours ago
      MA52TA, That's four sets of eyes. I'm willing to accept that it isn't there.
      Sleven,
      👍️ 1
      MA52TA MA52TA 6 hours ago
      I don't see it either. Maybe it will be published in the next few days.
      👍️0
      Number sleven Number sleven 7 hours ago
      Skipperdog, Thanks. It might not be there.
      Sleven,
      👍️0
      Skipperdog11 Skipperdog11 7 hours ago
      for what it's worth, this third set of eyes could not find Vaskepa as well.
      👍️0
      Number sleven Number sleven 8 hours ago
      TCI1, Good catch. You might be right. I'll look for that as well.
      Sleven,
      👍️0
      TCI1 TCI1 8 hours ago
      The approvals are all generics (Sandoz, Mylan, Teva, Dr Reddys, Hikma) - I don’t see any brands really so I wonder are there two separate documents
      👍️0
      Number sleven Number sleven 8 hours ago
      TCI1, Yes. I will try shifting through that mess again this evening. Unless someone else finds it.
      Sleven,
      👍️0
      TCI1 TCI1 8 hours ago
      Assuming it’s definitely approved for reimbursement.
      👍️0
      Number sleven Number sleven 9 hours ago
      TCI1, I didn't see it either. It must be in there somewhere.
      Sleven,
      👍️0
      TCI1 TCI1 9 hours ago
      Thanks Sleven. I don’t see Vazkepa on the list (although I might have missed it as it’s not reader friendly)
      👍️ 1
      abka abka 9 hours ago
      Right, Still now I blame John Thero for current situation of Amrn. He hired some friend lawyers to fight in Vegas. JT should burn in hell.
      👍️0
      Number sleven Number sleven 10 hours ago
      http://95.110.157.84/gazzettaufficiale.biz/emittenti/elencoEmittente9.htm
      Sleven,
      👍️0
      rosemountbomber rosemountbomber 12 hours ago
      Totally true. But I have to add that the random judge and random state was ultimately the result of management’s decisions.
      👍️0
      Jasbg Jasbg 12 hours ago
      We got played/killed by some smart generic loyers and a random judge in a random state.

      So much the USPTO stamp - that Amarin spend more than a decade and hundred of millions getting'.
      👍️0
      alwayswatching1 alwayswatching1 1 day ago
      CAPR having all the fun while we languish in hell. Maybe just maybe we have 1 more decent run for this POS stock to get us some of our money back. What a freakin nightmare this turned out to be.
      👍️ 1
      DMC8 DMC8 1 day ago
      👍️0
      DMC8 DMC8 1 day ago
      https://www.marketbeat.com/instant-alerts/nasdaq-amrn-analyst-earnings-estimates-2024-10-04/
      👍️0
      ramfan60 ramfan60 2 days ago
      Kiwi.....Nothing wrong with the numbers as you said. I did have excess body fat thanks to my Ben and Gerry's Covid diet so I managed to melt that off by avoiding carbs and burning fat for energy. That's what happens when you become fat adapted.

      I stopped taking the Lisinopryl because my BP normalized
      👍️0
      Whalatane Whalatane 2 days ago
      Re Prior to this, my standard American Diet lipids had me at LDL=95, TRIGS=40, HDL=80....what was wrong with that ?
      About BP measurements ...you probably know about the white coat phenomenon . Suggest you have the BP measurement done at least twice while in the office ...just after you arrive and again just as you are about to leave . If you can stop by a place like Rite Aid on the way home for a self administered 3rd measurement , all the better .
      Why no more Lisinopryl ?
      Kiwi
      👍️0
      ramfan60 ramfan60 2 days ago
      It will be interesting to see what my personal lab rat lipids look like in a couple weeks......as you may recall, I put myself on a super low carb way of eating. Mostly high fat meat, dairy, and eggs. Prior to this, my standard American Diet lipids had me at LDL=95, TRIGS=40, HDL=80. My BP was hanging around the hypertension levels of 140/90 and they prescribed low dose Lisinopryl. At the 6 month mark, I had LDL=200, TRIGS = 48, HDL=89.......no more Lisinopryl as my BP hovers in the 120's/80s....... so I'll see the vampire next week and see what happens
      👍️0
      Whalatane Whalatane 2 days ago
      Ram. agree ...good pt . My wife prescribes Statins to her CKD patients ,( has prescribed Vascepa ) but also can't tolerate a high enough dose of a Statin to get her LDL below 70 mg/dl .
      Kiwi
      👍️0
      ramfan60 ramfan60 2 days ago
      Let's not forget, these indications assume a certain level of ability to tolerate statins....... a case can easily be made that a patient does not tolerate something.
      👍️0
      Whalatane Whalatane 2 days ago
      N7. You wrote I would imagine they can make the patient fit reimbursement criteria....which indicates intent to defraud ...filing incorrect data ( LDL levels for instance ) in order for Vascepa to be reimbursed.
      That activity probably puts the MD at higher risk than prescribing off label .
      JMO
      Anyway ...if the story out of Italy was great AMRN would have PR'd it already .
      Good news hits the wires almost instantly . Less good / indifferent news seems to get lost ...MITIGATE data for instance

      Kiwi
      👍️0
      MA52TA MA52TA 2 days ago
      It's just paperwork... The reality is very different.
      👍️0
      seve333 seve333 2 days ago
      Dead silence from denner and his fund. They have not said a word in six months. That is what I know.
      👍️0
      seve333 seve333 2 days ago
      The stock is at .60 cents how much more damage can be done to it that denner has not already caused? The guy has proven to be a complete fraud in over his head. I guess he turned around a company once but its clear his lost his touch. The silence from his firm speaks volumes after they claimed how important communication was. To me they are complete liars who said whatever they had to simply to take control.
      👍️0
      CaptBeer CaptBeer 2 days ago
      Here are some notables from this article:
      https://kevinforeymd.com/reverseascvd/

      How To Reverse Atherosclerosis: Strategies For Those With Coronary Artery Calcium (CAC)

      1. Icosapent ethyl (VASCEPA®) can be effective in the reversal and regression of atherosclerosis (plaque), in statin treated patients regardless of their TG levels.
      2. A 1% reduction in plaque volume is associated with an 18% reduction in major cardiovascular events.
      3. Icosapent Ethyl plus Statin therapy achieved a greater reduction in total plaque volume as well as fibrous low-attenuation plaques, suggesting an additional plaque-stabilizing effect.

      Below is my illustration comparing plaque regression to CVE Outcomes in statin treated patients plus alirocumab (PCSK-9) vs. Statin treated patients + VASCEPA®. You can easily see the relationship expressed in bullet point #2 in the RRR from these two therapies.

      👍️ 8
      Number sleven Number sleven 2 days ago
      JRoon, I stand by that opinion. Reimbursement isn't a label restriction. "If" a doctor wants to put a patient on Vazkepa, I don't believe restrictive reimbursement will create an insurmountable barrier.
      Sleven,
      👍️ 1
      JRoon71 JRoon71 2 days ago
      I would imagine they can make the patient fit reimbursement criteria.

      That's what I was responding to.
      👍️0
      Number sleven Number sleven 2 days ago
      JRoon, You are responding to things I didn't write.
      Sleven,
      👍️0
      JRoon71 JRoon71 2 days ago
      You're also making a huge assumption that doctors are so emphatically moved by Vascepa that they are willing to push the envelope on script requirements and documentation in droves.

      Since this has not happened in the U.S., Canada, the UK, or Spain, what leads you to believe that Italy is somehow different?

      All of EU is approved for use, and more than a handful are approved for reimbursement with ZERO scripts written.

      I would love to be optimistic, but there is zero evidence that any significant number of doctors, on ANY continent, are prescribing Vascepa like crazy. In fact, the opposite is happening - there are other drugs that are leapfrogging Vascepa in the standard of care regime.

      Did you see what was written about Vazkepa by AIFA?

      "Although demonstrated in comparison with a placebo probably not completely inert and in a population not treated on top of the drugs recommended for the reduction of LDL cholesterol, the data of the study seem to configure an important added therapeutic value. The certainty of these data, however, is not sufficient as detailed in the section on the quality of the evidence."

      QUALITY OF TESTS: Low
      COMMENT: The pivotal REDUCE-IT study, a randomized placebo-controlled trial, was considered in the GRADE_Pro assessment. The lack of reproducibility of the results (the only study with results not consistent with those of other drugs in the same class) and the lack of generalizability (patients not treated on top of the drugs recommended for LDL-C reduction and in the absence of information regarding any dietary control) determine the application of two downgradings to the quality of the evidence which is therefore to be considered LOW.
      OVERALL JUDGEMENT ON INNOVATION: The drug is not recognized as innovative in light of its moderate therapeutic need, significant added therapeutic value, and low quality of evidence.

      This is what doctors are seeing in Italy
      👍️ 1
      MA52TA MA52TA 2 days ago
      It's just paperwork... The reality is very different.
      👍️0
      Number sleven Number sleven 3 days ago
      Kiwi, Is Italy part of the EU? Italian reimbursement decision will not alter the label.
      Sleven,
      👍️ 1
      DMC8 DMC8 3 days ago
      https://kevinforeymd.com/reverseascvd/
      👍️0
      DMC8 DMC8 3 days ago
      https://www.dispensingdoctor.org/news/dda24-reducing-cv-risk/
      👍️0
      Whalatane Whalatane 3 days ago
      Absolutely no risk ?

      When prescribing off-label medications in Italy, physicians have several important liability considerations:

      Legal Framework
      The main law governing off-label prescribing in Italy is Law 94/1998 (also known as the Di Bella Law)1. This law allows off-label prescribing under certain conditions:
      It must be for an individual patient
      The physician must determine that approved on-label medications cannot effectively treat the patient's condition
      There must be scientific evidence supporting the off-label use, including favorable results from completed phase II clinical trials
      The patient must provide informed consent

      Physician Liability
      When prescribing off-label, Italian physicians take on increased responsibility and potential liability:
      They have a direct responsibility for the off-label prescription3.
      They may be called to respond to any problems arising from the off-label use as if they had done something outside the standard of care1.
      The burden of proof rests on the physician to demonstrate the off-label use was appropriate1.
      Key Liability Considerations
      To mitigate liability risks, physicians should:
      Thoroughly document the rationale for off-label use and scientific evidence supporting it
      Obtain and document informed consent from the patient, clearly explaining the off-label nature of the prescription4
      Closely monitor the patient for adverse effects
      Stay up-to-date on the latest evidence and guidelines regarding off-label uses

      Potential Consequences
      If problems arise from off-label prescribing, physicians may face:
      Administrative liability
      Potential requirement to personally reimburse costs
      Professional disciplinary action
      Civil liability claims from patients
      However, if proper procedures are followed, off-label prescribing is legally permitted and can be an important treatment option2.

      The key is ensuring it is done responsibly with appropriate documentation and patient consent.. my emphasis ...just what MD's want everywhere ...more paper work

      Kiwi
      👍️0
      MA52TA MA52TA 3 days ago
      Absolutely no risk. Completely different from the USA.
      👍️0
      MA52TA MA52TA 3 days ago
      I think he has a lot of discretion to prescribe. I know how it works, I am Italian, even if I currently live abroad. Of course, either the doctor or the patient must be informed of the benefits of prescribing VAZKEPA.
      👍️0
      Whalatane Whalatane 3 days ago
      N7. Theres plenty of risks...to the MD .... in doing what you appear to be advocating .
      I wouldn't count on it
      Kiwi
      👍️0
      Number sleven Number sleven 3 days ago
      JRoon, I agree that reimbursement is the important piece. If doctors want the patient to receive the medication, they will work the system. I have no doubt they have experience.
      Sleven,
      👍️0
      Number sleven Number sleven 3 days ago
      RMB, If an Italian doctor wants his/her patient to be on a particular therapy, how much latitude do you think they have. I would imagine they can make the patient fit reimbursement criteria.
      Sleven,
      👍️0
      JRoon71 JRoon71 3 days ago
      RMB, I also agree with this. As I had posted the other day, with such specific and restrictive criteria, it is hard to imagine a significant amount of scripts being written. BUT...it gets our foot in the door. There is always the possibility that criteria are reduced in the future if RWD confirms positive outcomes.

      The critical piece is getting reimbursement in place in Italy and France.
      👍️0
      JRoon71 JRoon71 3 days ago
      Sleven, that's a reasonable assumption.
      👍️0
      CaptBeer CaptBeer 3 days ago
      On World Heart Day, it's important to recognize that over 40 million deaths were attributed to cardiovascular diseases (CVD) across six world regions, with 3.4 billion confirmed cases in 2021, as reported by the Global Burden of Disease Database. Fortunately, cardiovascular events can be reduced by 25%, and cardiovascular deaths by 20%.

      👍️ 1
      rosemountbomber rosemountbomber 3 days ago
      Have to agree with your reasoning Sleven.

      Having said that, the restrictions imply to me anyway, that scripts will be meager there. I remember many years ago how most of us here ridiculed the analysts who put such very little value on the EU. Obviously they knew that the road there was going to be a tough slog.
      👍️0
      tke458 tke458 3 days ago
      I share that opinion and we will see.
      👍️0
      Number sleven Number sleven 3 days ago
      Always, I don't read Italian. That said, looking at the documents available, I have an opinion. I see a list of restrictive criteria. I think that list would be unnecessary if reimbursement was denied.
      Anyone disagree with that opinion?
      Sleven,
      👍️ 1

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