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This is a great study! Thanks for sharing this, DMC.
MRM, not so sure. Keep in mind they are limited to about 375,000 shares per day, give or take. They can buy 25% of the average daily volume over the prior 30 days.
It's pretty easy to hide 375K or less shares during the day.
But we'll find out at the earnings call if they have been buying (at least up to June 30th).
This volume does not look like the buy back is currently in motion.
How does eicosapentaenoic acid (EPA) exert its cardioprotective effects? This in-vitro study suggests EPA reverses IL-6-induced endothelial dysfunction via numerous protein changes and increased nitric oxide release. #AHAJournals @DLBHATTMD https://t.co/FahOYBVz4N pic.twitter.com/SWnVGGwsVY
— JAHA (@JAHA_AHA) July 18, 2024
Gleaned so much from our board today. I know who's going to win the Open, Shane Lowry! Rory misses the cut. Greg Norman is a bitter old man and not good for the PGA. Carry on guys I cherish your personal opinions. Nice to know we only have 109 days to go! Oh I almost forgot what's wrong with AMRN?
Nuke, I understand. The primary topic of discussion for this board is Amarin. When conversation starts to swing in a different direction, I need to say something.
Sleven,
OT: Bob Newhart passed today. Touching little vid covering the friendship between the Newharts and the Rickles:
https://www.newyorker.com/video/watch/bob-and-don-a-love-story-a-short-documentary-by-judd-apatow
Put an end to the political discussion.
Sleven,
Curious about the issue in Germany, I found the IQWiG assessment. It’s challenging for Amarin to bite the hand that feeds it. Raising awareness of this unreasonable stance through German media could be effective. If someone has connections he would be more than welcome to use this analysis to do so.
Rose, where's bidens mask as he boarded plane. Lol gabbed 3 times. Lol
Ramfan, rumor has it biden will not endorse harris and dems will have an open convention. Let the games begin.
South Pacific, when was this data screw up discovered?
Does amrn have any recourse?
Shocking
Old but unfortuntely still actual
The German IQWiG Confuses Enrollment Criteria with Mechanism of Action
In Germany, the Institute for Quality and Efficiency in Health Care (IQWiG) provided the scientific evaluation of IPE. It claimed that IPE was not compared to a maximally optimized LDL-C lowering therapy called the accurate comparator therapy (ACT), making it impossible to isolate its efficiency (see annex 23). It stands alone in this assertion, as it is contradicted by IPE's approval by all major regulatory agencies. The IQWiG appears to have erroneously conflated the REDUCE-IT trial's requirement that all patients be on statin therapy with LDL-C lowering itself, mixing up enrolment criteria with the mechanism of action. Rationality dictates that drugs should be tested based on their biological targets or mechanisms of action, not according to enrolment criteria, which only define the targeted population. IPE does not pursue LDL-C lowering.
IQWiG’s request that LDL-c therapy be maximized only makes sense when evaluating a drug intended to further lower LDL-C levels beyond what existing therapies can achieve. In contrast, IPE, as any non-LDL-C lowering drug, provides cardiovascular benefits independent of further LDL-C reduction. These drugs are compared to their own benchmarks. For example, a new anti-hypertensive drug is benchmarked against the best current blood pressure-lowering treatment but not against an LDL-C lowering therapy. If a drug, like IPE, is the first in its category it has to be compared to a placebo and not to an optimized LDL-C lowering therapy.
In clinical trials like REDUCE-IT, contrary to IQWiG’s assertion, ensuring standard medication consistency across groups (e.g., LDL-C lowering, blood pressure-control, diabetes treatment) is sufficient to isolate the new drug's specific effects. This is standard practice. Trials testing SGLT2 inhibitors, GLP-1 receptor agonists, colchicine, or Rivaroxaban did not require strict LDL-C control as now requested only for IPE, yet cardiovascular benefits were evident.
This lack of understanding from the IQWiG’ committee in charge of the assessment is bewildering and has two consequences.
IQWiG's Self-Inflicted Impossibility:
Imposing this irrelevant ACT criterion would unduly restrict icosapent ethyl (IPE)'s application, limiting its use to patients with extremely low LDL-C levels, should a new trial adhering to their requirements ever be conducted. This would be really absurd and a major waste for patients given its proven efficiency at any LDL-C level below 100 mg/dl.
Double Standard:
No non-LDL-C lowering drug has ever been restricted to this extremely low LDL-C levels.
A scandal in the making?
The Federal Joint Committee (G-BA), Germany's top healthcare decision-making body, cannot contradict the EMA's approval of Vazkepa, but it can set its price based on perceived cost-effectiveness. By setting remarkably low prices for Vazkepa, comparable to those of mere supplements, the G-BA effectively endorsed the deeply flawed IQWiG's assessment of icosapent ethyl's value, making economically unfeasible for Amarin to promote Vazkepa. This has led to Amarin's justified refusal to accept these terms, resulting in unnecessary delays.
Delays in drug approval are normal, yet unreasonable delays are indefensible. The longer these extraneous delays persist, the higher the risk of pointless deaths and CV events. It is imperative that the German agency act promptly to rectify its misunderstanding of Vazkepa efficacy.
You meant to say as dry as a "Pop Corn Fart!!!" First Spain, now Portugal, next..... France (IMHO). Lithuania maybe?
I don't see how they get around putting Cackling Kamala out front. It would be a bad look for the Democrats not to.
Hmmm, you mean all this time the annual flu shot scam that's been going on for decades is absolutely no good at all in preventing the flu? Say it isn't so?
the question is : wo would take his place?
One of the first thoughts that popped in my head when I heard. A way out for him.
Color me skeptical that he actually has Covid....... quite the coincidence when he really needs to stay out of the public eye and the fawning media while deciding on how to drop out of the race...... I smell a cornpop
Vaccines don’t stop a person from catching a virus.
You mean the same Amarin that lost their patents to litigation in the first place? And then lost on appeal again?
I'm not saying it's not worth pursuing. You have to. What I am saying is that I don't see the outcome being as monumental as some might think.
JRoon, You should probably contact Amarin and their legal representation. You can explain why pursuing this litigation against Hikma is simply a waste of time and capital resources. Clearly you have a better understanding of the situation than they do.
Sleven,
Jim, that would be great. Then we just need the other 6 generics to exit the IPE market as well.
Sleven, it doesn't matter. All that matters is if ANY of the generics keep selling.
Just like it didn't matter that we "won" (settled) with Healthnet. All that meant was that other insurers/PBM's just dropped us.
I would love nothing more than for all 6 or 7 generics to stop selling IPE. But I doubt that happens.
I'm not an attorney, but one thing Hikma has to worry about is big Pharma getting into the Vescepa game. With that prospect, Hikma settles. No long game here, the settlement gets Hikma out, then Hikma can avoid going to the mat with the big boys, where there will be no mercy.
Let’s stop calling it a vaccine.
Joe Biden has COVID, he was vaccinated too. Shows you how effective the vaccines were. What ever happened to Mitigate? Who steps in? Obama or Kamala Harris?
Thanks for the post Capt: I'm debating on whether or not to get a Twitter account. I never go there, as I don't particularly care for Social media. Too many eyeballs.
Repeat after me, “It’s the EPA Stupid!” https://t.co/Nu1RX8ad5x
— Mike Everts (@GeoWizz_) July 18, 2024
Mic drop!!! What no rebuttal?
It was great! I would have rather done it in 10 or 11 days but my friend wanted to push it
and we averaged over 20 miles for the first 5 days. The key is to carry a VERY light pack. We only had two sets of clothing and hand washed a set each day...hung out to air dry. I was wearing two sets of compression
as I injured myself over training before the trip. Yes, when you are doing that much mileage a day
you can eat and drink what you want without worry of putting on weight! (o: Plenty of information
online so you can do the research ahead and feel comfortable about what you are getting into.
Thanks Bob; only a matter of time. Spain & Portugal share common beliefs. Let's hope that it's neighbor France will do the same. I think once France caves, we'll really start getting some traction. French are very smart people. I really respect their stance on Nuclear power. They make really good wines too... :D), but so do the Spaniards and Portuguese. I especially like the Spanish Grenache, Syrah and Mourvèdre blends (GSM).
A number of posters (thinking Orbapu here) have posted the evils of PBMs. Here is another article (opinion piece) highlighting the same. Sorry if already posted:
https://www.latimes.com/business/story/2024-07-11/column-pharmacy-middlemen-claim-to-keep-prescription-prices-low-in-fact-theyve-cost-consumers-billions
JRoon, Nothing has changed? Do you think Teva never stopped selling that product?
Sleven,
I'm sure that will get worked out in 3-5 years.
Hikma, and all of the generics, are just going to drag this out and play the long game.
Everyone thought the Healthnet case was going to put the nail in the coffin for insurers. And look what that did. We lost 25% of our business overnight.
The GSK/Teva case has been going on for 10+ years, and no money has changed hands, and nothing has changed.
I have little belief that this lawsuit is going to have a material impact in the short-term.
JRoon, Doesn't have CVD listed as a limitation of use. Only pancreatitis. That is the primary issue with every generic label. The absence of that language tells a doctor that gv is appropriate for the R-IT indication. It was argued in the appeal.
Sleven,
ABC, my assumption is that they were just smart from the start about their label. I assume most of the other generics labeled correctly as well (though I don't have any firsthand knowledge that this is the case). So yes, they are all clear as far as induced infringement if they labeled and marketed correctly.
With regards to docs prescribing, I don't think doctors really look at labels specifically. They look at equivalency. Since it appears that more docs (or pharmacies or insurers) are prescribing generics, I really don't think the label matters to them. I don't think this case is going to do anything in the short-term for Amarin. Long-term (like, 3-5 years or more down the road) it might have an impact on the industry, and if Vascepa is still facing the same headwind in the U.S. with whatever BP owns it at the time, then it could help THEM. But I don't think it helps Amarin.
JROON,
I notice that Camber avoided the CV indication in their patient info and restricted it to high Trig. Do you think they got wind of the ongoing appeal case where the (judge?) made strong statements about not infringing using the CV indication on the Label. If all gV makers decided to do the same, they would be off the hook legally. Would doctors still prescribe gV for CV? Would pharmacies still substitute gV for CV? At least, we patients would find it easier to cry foul, to both the doctor and the pharmacist. Dave
RT- thanks for the awesome trip idea. I have already started the research. I think walking 18 miles a day should counteract the weight gain from the great food.
IMO you cannot really rely on numbers provided by Portugal dept of health as they lag in time and accuracy. They have not produced any in depth numbers since 2021. I suspect the numbers are much higher that these reported.
Moreover, do these numbers includes: "Exposure to air pollution has been associated with increased mortality, premature mortality, and morbidity. A causal relationship between fine particulate matter (PM2.5) exposure and cardiovascular morbidity and mortality was demonstrated by the American Heart Association".
If I retired there I would weigh 800 pounds... those Pasteis de Nata are so friggin' good!!!
Great country, food and great people. I just did the Porto Camino de Santiago this past May
with my wife and a good friend. 162 miles in 9 days.
Interesting. Less CV incidence in Portugal but proportionally more CV deaths. Although a different country, since it is beside Spain hopefully the launch is as good as Spain's.
Another small piece in place.
biggest waves, best meds - I should retire there.
and I want to hear details about the buyback.
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