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Monk, He's been on ignore for years !
Problem is' that on iHub - he's posts still turns up on your screen - when answering other posters - you follow.
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I have pointed this out to iHub leadership (putting people on ignore - as of now - is an illusion) - something iHub hopefully will address, at some point !
Kiwi’s MO is to piss you off and get a response. Put him on ignore as I’ve done long ago and. Just don’t give him fuel
If he can’t piss anyone off anymore he’ll go away
My comments were in the context of the previously posted article:
“Lipoproteins, Cholesterol, and Atherosclerotic Cardiovascular Disease in East Asians and Europeans.” https://www.jstage.jst.go.jp/article/jat/30/11/30_RV22013/_html/-char/en
The JELIS Trial has over two decades of Evidence and over a decade of Rx exposure in Japan. I’m pretty damn sure if EPA was a “false positive” and had no clinical benefit, as that numbskull Nissen said, it would have been removed from the market. When in fact after 10 years of generic competition it still enjoys 60% market share.
Yep! They’re convinced in Japan, and apparently in China too as they are not requiring another outcome trial for CVD. I don’t have any knowledge regarding what South Korea, Malaysia, or Thailand may require but I also doubt they would require another outcome trial.
caddiedad, And who other than Whala (+20.000 posts - trying to undermine Vascepa and the Reduce-It trial) !!!
What are his motives for using 'these endless hours on a subject - of 'officially' no personal economical interest to him ????
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And referring crap like this - is an insult to every honest and serious poster on this board:
Some experts, like Dr. Steve Nissen, felt the many limitations of the RESPECT-EPA trial made the results uninterpretable and that it should not be used to support the data from the REDUCE-IT trial.
Thanks Dr. Steve for your concern and bashing of V over the years. Scorned much?
Based on the search results, here are the key things Amarin would need to do to get reimbursement for Vazkepa (icosapent ethyl) in Germany:
Reach a viable agreement with the National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement price for Vazkepa:
The search results indicate that after four rounds of negotiations, Amarin and the GKV-SV were unable to reach an agreement on the reimbursement price.
The matter was escalated to the Arbitration Board for a final decision, as the two parties could not come to terms.
Potentially use real-world evidence and data to support the clinical benefits of Vazkepa:
The search results mention that there is a precedent in Germany where a product that received a negative reimbursement decision was able to get it reversed by using real-world evidence and data to demonstrate the clinical benefits.
Amarin indicated they may explore a similar path to resubmit the file in Germany.
The key criticisms of the RESPECT-EPA trial were:
The trial was underpowered and failed to meet its primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina requiring hospitalization, and coronary revascularization. The reduction in this endpoint was of borderline statistical significance (p=0.055).
The trial had a high number of patient withdrawals or protocol deviations, which added uncertainty to the conclusions.
The open-label design, without a placebo control, was a limitation that could have introduced bias.
While the trial showed a signal of benefit consistent with previous trials like JELIS and REDUCE-IT, the magnitude of the potential cardiovascular benefit was uncertain.
There were concerns about the increased risk of atrial fibrillation seen with icosapent ethyl, which could offset any potential cardiovascular benefits.
Some experts, like Dr. Steve Nissen, felt the many limitations of the RESPECT-EPA trial made the results uninterpretable and that it should not be used to support the data from the REDUCE-IT trial.
In summary, the RESPECT-EPA trial was criticized for being underpowered, having design limitations, and failing to provide definitive evidence on the cardiovascular benefits of icosapent ethyl, despite showing a signal of potential benefit.
See my previous comment. There's no sense in re-beating that Dead Horse.
EPA not EPA+DHA could be beneficial ;however, further investigations are needed
As an additional comment to this conclusion by the authors, I don't believe that additional RCT's are needed to prove the efficacy of IPE. They didn't mention the results from RESPECT-EPA another Japanese RCT that showed a 26.6% RRR in secondary prevention (p=0.03), and a 21.1% RRR in Primary Prevention (p=0.054). Furthermore, there's been a bunch of recent studies to support that it's not Just about LDL-c, ApoB, Lp(a), TG's, or the placebo.
It's the EPA Stupid!
RCT's in East Asian Populations have shown a "causal association of elevated remnant cholesterol with increased risk of ASCVD."
"In the East Asian context, in the JELIS trial with 18,645 Japanese individuals with hypercholesterolemia, EPA on top of statins showed a 19% relative reduction of major coronary events. From these results as well as the results from the REDUCE-IT trial, EPA not EPA+DHA could be beneficial; however, further investigations are needed to conclude the efficacy of omega-3 fatty acids."
"This excluded the unused $1.6B tax loss credits" .I'm sure a BP would know how to recover this money.This alone gives a value of about $4 per share.
Extract from latest Q1 2024 10Q.
Sum up accounts receivables, current & long term inventories, AMRN has additional about $445m total assets on the balance sheet, on top of the cash on hand $308m.
This excluded the unused $1.6B tax loss credits.
With 410m shares float, AMRN’s intrinsic value is way much higher.
Not forgetting China’s rapid TG uptake of 100% growth on debut quarter. China will be the largest big bang for AMRN, both in terms of supply clearing and BO valuation.
Dear Kiwi,
Every one agrees with all the concerns that you mentioned here in this post. No one is ignoring them.
What I don’t agree is you saying management is not doing anything to address it. And that they are just waiting and watching and in the interim their only plan is to use the $50Mil buy back to support the SP. That acquisition is as naive as it can get.
And of course you also know it very well that Amarin is not going to spend money to run another trial to revalidate reduce-it outcome, which you keep pushing for. Because that would be the most ridiculous thing for Amarin to do.
Nuke, I think you misunderstand my post. Kiwi is criticizing our current management for not running more clinical trials. I am actually defending both current and past management. I think it would be a waste of money to run any more trials to prove the value of icosapent ethyl for cardiovascular risk reduction.
Do you disagree?
You made your decision about who you think should be running the company, and your not whining about what they are doing. I have no problem with what I have seen current management do to date.
Sleven,
Geez, give it a rest willya? Denner and company is still cleaning up the mess from the previous “inept” management scum bags.
Thanks I’ve been waiting for the actual peer reviewed journals from the ACC24 Presentations.
Effects of icosapent ethyl according to baseline #residual risk in patients with #ASCVD: new evidence from the REDUCE-IT trial now out with #openaccess in #EHJPharmacotherapy 👉 https://t.co/4LYIT0fb5x @EditorEHJCVP @FeliceGragnano @MattiaGalli10@DLBHATTMD @gabrielsteg pic.twitter.com/bsKSFQCMt6
— European Society of Cardiology Journals (@ESC_Journals) May 4, 2024
Kiwi, By the way. This new management team is who you endorsed.
Sleven,
Kiwi, If you want the company to make different decisions, talk to them. I can only track decisions that they make. How long did it take for statin drugs to gain traction? You apparently don't believe that the drug has clinical value. I do. Generic competition is forcing the price cuts. This is killing our margins and profit in the US. Is this a surprise for you? I believe both past and current management understand how to deal with this problem. Supply chain will be the key
Once again I urge you to sell your position and move to a company that you can understand.
Sleven,
Well your mindsets seem to be to stick with the same ol same ol ...cos eventually ....eventually , the entire Cardiology community will see the light and start aggressively writing scripts ..especially in the EU
Meanwhile ...do the math here, Q1 24 over Q1 23 saw a 41% decrease in US revenues . Similar will happen in Q2 and Q3 and Q4 because the major health providers like Kaiser have switched to generic V or are forcing AMRN to beat generic pricing to retain their market share .
Great deal ..hey we have retained our US market share ...but were losing $ doing it ..but never mind
And while this is going on in the US ...script growth ( except in Spain ) is barely moving .
But lets stick with the same ol same ol ...with a $50m share buy back thrown in so mgt options that vest next April, can maybe cash in .
Cos thats the best idea we ( mgt ) can come up with .
Kiwi
Chromosome, I think you and I have a similar mindset. I look forward to more conversations. Enjoy your weekend as well.
Sleven,
Thanks NS…I was referring to the post remand decision by the district court…assuming it goes back which from the tone of the call seemed to indicate it will..
Anyways thanks. I always enjoy your posts as I feel it it one of the more informed ones. I also enjoy contrarians that are well research like Tatsumaki who although I don’t agree with at least has well articulated reasoning.
I work in oncology now and it’s amazing how easy it is to get accelerated approval based on surrogate end points like ORR and people are asking for more trials to prove what is already proven through the Reduce-IT gold standard.
Enjoy the weekend everyone…and the beer
Chromosome, I agree with your opinion about the European market. It's a time issue. As far as the infringement suite goes, the court of appeals can't actually make any rulings that directly effect either party. They are simply making a determination about the dismissal by the lower court. If they send it back, the suit picks up where it left off.
Sleven,
Thanks NS. I listened a couple of times. I am not a legal expert but am wondering if there is a scenario where it’s gets remanded and Hikma is forced to specify the indication in their marketing material but not face any retroactive monetary damages. My other thought is even if it gets added to their website and other marketing material, whether Dr.’s will actually pay attention to the new wording. Without any reps visiting Dr.’s, it’s hard to educate the physicians.
Bigger picture, for me personally everything positive that may happen in the US is a welcome and somewhat unforeseen upside. oUSA and especially EU market is big enough to warrant an attractive valuation…eventually. You need the patience of Job , which I have and I suspect most of the well informed posters here do as well.
Again, all jjust my opinion.
Have a great weekend.
RMB, I agree.
Sleven,
Chromosome, If you hadn't I was going to give you a link to the audio. It sounded like the court was going to remand this.
Sleven,
Yes NS, I did…..and?
Sleven I think things went pretty well for Amarin at the Appeals court. I am guessing remand but I am mostly interested in the wording and instructions of their order.
Chromosome, Have you listened to the oral arguments at the circuit?
Sleven,
Damn spell check..meant Nissen
Well Kiwi, I believe for people like Nissan and his buddies, no amount of evidence is good enough because their egos have been hurt and they will find another excuse to poo poo the results. Ignoring the US, just the big 5 in Europe should suffice for a reasonable valuation. Typically on the US market share in class peaks at 12-18 months (we have looked at a bunch of analogs). In Europe, the time to peak is much longer as it takes longer for the markets to build. With our new runway to 2039, that’s plenty of time. Plus and AG and China plus a little here and there, there is plenty of cause for optimism. Plus throw in a bit of legal upside (albeit low probability in the US). Of course that’s just my opinion and everyone should invest at their own risk.
https://eas-congress.com/2024/. Big Cardiology conference in the EU coming up
What's AMRN presenting ...anyone ?
Alright
Beyond LDL-c: Residual risk and Elevated triglycerides - Industry session sponsored by Amarin
Welcome and introduction
Presenter
Michel Farnier (France)
Lecture Time
14:45 - 14:50
Residual risk and Elevated triglycerides: Where do we stand in 2024?
Presenter
Lale S. Tokgözoglu (Turkey)
Lecture Time
14:50 - 15:00
Icosapent Ethyl in clinical practice : Who needs it the most?
Presenter
Azfar Zaman (United Kingdom)
Lecture Time
15:00 - 15:10
Icosapent Ethyl in clinical practice: What mediates the protective effects?
Presenter
Lluis Masana (Spain)
Lecture Time
15:10 - 15:20
Chromosome ..Well I am definitely in the minority .
You may think R-IT is the gold standard but because of the placebo used some major figures in the Cardiology world don't buy it .
Capt has a long list of non believers .
This affects script uptake here and in the EU
The current trajectory for AMRN ....significant decline in US sales , combined with minimal sales in the EU indicates a slow steady decline to oblivion ...not a BP buyout.
So what to do about that ?
Apparently nothing according to most on this board
Kiwi
Jim I was on Mevacor . Back then it was only for the HeFH indication I believe. Approval for primary prevention etc for CAD came years later ...1995 I think .
Above is just from memory .
The big change was Lipitor . I was given free samples that lasted about 6 mths ...handed out like candy on Halloween, when that hit the market .
Did you sell Lipitor ( Atorvasatatin ) also .?
Kiwi
Not everyone is a statin user, or tolerant to statins.
IMO I'd love to see a study without statins, but not paid for by Amarin but by its acquirer. That would LAUNCH Vascepa/Vazkepa to the stars!!! Seriously.... (BTW, statins limiting cholesterol may have a brain affect called Alzheimer's -- not a joke).
Not really a bribe. It is fairly obvious from Kiwi's wife's and your experience, these trips, lunches etc., are SADLY what it takes to get some of these MORONS/physicians, to learn about something new. You really think these docs are going to sit in some conference room with coffee and toast to learn about some NEW CVD drug??There's a new one out every day!! What's really despicable, SOME interventional cardiologists are only making money when they're in the Cath Lab and purposely won't use anything not in the ATP guidelines!! I remembering selling Mevacor, the first "statin" drug in a huge metropolis, Cardiologists were some of the last docs to start Rxing. Every other industry in US is allowed to take these "reward" trips from their vendors, but not Physicians, or those in powerful positions in the hospital, i.e., CEO, administrators, etc. Medicine is corrupt and in serious decline, like everything else.
Because he’s the eternal pessimist. Still not totally convinced he isn’t Nissen lurking around here to torture us longs
Kiwi, I am not sure why you keep saying that AMRN should sponsor a small trial focused on sub-groups. Reduce-IT was the gold standard. There is still positive data coming out for and RWE is also emerging. If any investigator wants to further investigate, they are free to do so and I am sure AMRN can give them free drug but a full sponsorship, given the preponderance of data does not make financial or any other sense. I agree with NS; the rest of EU will eventually come on board. If anything, a better HEOR dossier leveraging RWE may be more effective.
Another example of a short CAD trial ...this time in Sweden
The SWITCH-SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial.
The trial aims to systematically evaluate the transition from using ticagrelor to using prasugrel as the preferred P2Y12 inhibitor drug for treating patients with acute coronary syndrome (ACS) in Sweden.
The administrative regions in Sweden will constitute the clusters, and the order in which they switch from ticagrelor to prasugrel will be randomly assigned.
The primary endpoint is the composite 1-year rate of death, stroke, or myocardial infarction.
The trial will establish an important standard for introducing and evaluating the effects of healthcare changes within the Swedish healthcare system.
The trial is designed to provide a systematic, randomized comparison between the use of ticagrelor versus prasugrel for treating patients with ACS in a real-world setting.
Try this with available Kaiser data
PRECLUDE-2 was a Swedish registry study involving over 100,000 post-MI patients. It found that the majority of these patients who have at least two cardiovascular disease risk factors showed a marked but gradual increase in incidence of cardiovascular death, MI or stroke during the follow-up period of three years. If all five cardiovascular risk factors studied were present, there was up to a nine-fold increase in incidence of CV events, compared to when only one risk factor was present.
RMB. As I have posted before . You pick a R-IT subgroup with a high risk reduction where the event lines separated fairly early . The Revasc rates ...especially second revasc rates as an example.
Real life example .
Wife was unable to dialyze one of her patients recently because he was complaining of chest pains . Sent to the ER where they found one of his coronary stents had re occluded ( plaque had reformed possibly as a result of injury to the vessel sustained at time of PCI ) .
Patient was not on Vascepa
So run a short trial ...or at least look at Real World evidence for these patients ....Kaiser must have lots of it by now.
SOC ( standard of care ) vs SOC plus Vascepa ...follow rates of re occlusion following a recent PCI .
Huge cost savings if re occlusion rates fall for those on Vascepa .
No placebo , open to all TG levels
Kiwi
Good insight. Only other thing it could be would be that they know the company is grossly undervalued and they can get a better return on their money than any other investment or expense.
I don't think (could be wrong) that the study you posted was done by a BP. And additionally, 68 weeks as they only had to show a reduction in LDL. With Vazkepa you wouldn't have one biomarker that you could show but would need to have a much longer duration trial to show MACE benefits. Now, if it just involves collecting, collating, analyzing existing data from patients in the RW taking V for the last 5 years, fine.
Well, when Denner suddenly starts buying and crosses 10% ownership, you'll know he already has an offer in his back pocket and has to wait 6 months before telling anyone else.
All the trips, the dinners, the fancy swag bags filled with expensive goodies is still alive and well. It's just shifted up to people with the authority to change Rx habits in an organization. You said it yourself, your wife doesnt have the autonomy to Rx a new drug on the market. Why spend those efforts on someone in that situation? Reps will focus on the dept. heads, executives or PIP developers. The consolidation of smaller clinics in to larger managed care operations just made it easier to manage for the pharmaceuticals from a top down approach vs. chasing after thousands of individual Drs. Win win for everyone as the clinic can spin the "we dont allow big pharma reps to bribe our Dr's" and BP can work over fewer people for the same impact.
Kiwi, What you think the company should do is irrelevant. We are investors not board members. We don't get a vote. You and I have access to the same information. We disagree about the outcome. If you are convinced that the Vascepa market won't grow, sell your position.
Sleven,
Snd. RWE studies are done all the time to inform regulators and physicians ...I've easily identified several .
Heres one on PCSK9's in Germany
A real-world, single-center study that examined the use of PCSK9 inhibitors (alirocumab and evolocumab) in a large patient cohort (n=635) in Germany. This study was conducted at the lipid clinic of Charité Universitätsmedizin Berlin and assessed the prescribing patterns and treatment outcomes of these novel lipid-lowering therapies in a clinical practice setting.
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