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Thank you NS for sharing this.
Those who have been around the MB for a lengthy period know that I am a huge advocate of Vascepa/Vaskepa.
When I read the article the use of V in this setting is very specific. Notice it is an update from its 2021 meeting.
It is for a condition where the arteries in the extremities of the body build up plaque and restrict blood flow. This can lead to increased blood clots which can lead to strokes, mitral infarction, obvious pain and even death of a portion of the extremity if blood flow cannot get to it. It was very promising that over 80% of these distinguished experts recommended " For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram."
Getting 80% or greater of these French experts to agree is extremely positive. So as the article says, now the experts have a standard to use with this particular condition and when certain blood values are still not in alignment even after being on max statins etc. It is promising that it says "Icosapent ethyl should obtain reimbursement soon in France."
I am not trying to be pessimistic but realistic. I have heard different things however the status in these countries is always dynamic and flowing. My understanding was that we will eventually get approval but it most likely will be well into the second half of 2025. I would love nothing more than to have this time line moved up. One thing which the French government looks upon for renewal is not only the medicinal value of the product but also how the company plans to help in the boosting of the economy as well. It could very well be that some of this infrastructure has taken place. Are there any manufacturing facilities in France producing or encapsulating IE? I'm not smart enough to find this but I know you watch this closely.
Bottom line at least for me is that I love the statement but until I can hear an update at the next CC from Berg, I'm going to be critically optimistic if that makes sense. What does make sense is that IE should be used for those with LEAD. Many more patients would be blessed with less strokes, heart attacks, pain, surgery and amputations.
As a side note, I have no clue on how the Chinese situation is going with Edding moving through with all the paperwork hoping for V to be on the government formulary for CVD in January. If anyone can see progress in this area it would be appreciated.
Germany is miles away still. The Germans are irrational not tying V into their healthcare. I understand the budget restraints but they would make up the difference in the 5 plus years with lack of 5 CVD conditions.
We are in good shape in Italy. It is a formality now but will have to wait until officially announced.
As always appreciate your posts and comments. Hopefully this does not come across as some "know it all" posting. Just typing as I'm processing this in my brain. Let's cross our fingers and hope we get a positive SPECIFIC update about France at the next CC and not just a "we hope to have reimubursement decisions in 2025 for France". Take care brother!
Nuke, I think their waffling by using the word should was referring to whether reimbursement would be granted (not something in their hands) and not whether V’s drug benefits were valid.
Hi rose, I disagree of course. Simply because the Reduce-It results have been out there since 2018, 6 years…
Either none of these scientists didn’t do any research or any fact finding is no excuse.
Maybe the French Authorities will overlook the semantics, but knowing how good the French are a designing and running their Nuclear Plants I don’t think they will do anything until they do their own research.
We are all morons more like…
Congrats on your accurate diagnosis .
Hope alls well in LV
Kiwi
We are all amariaddicts. Otherwise why in the world would any of us still be here. Except of course our beloved paid bashers and those bitter souls who sold for epic losses.
Bought a few more shares today. Lord help my addiction.
Captain, Love your graphics.
Sleven,
North, Nuke,……
North, the answer to your question is that is the opinion of the authors of the paper not Kiwi. Kiwi only highlighted that part in bold for emphasis.
https://www.sciencedirect.com/science/article/abs/pii/S0890509623006799
Nuke, I see them using the word should and not may, but of course there isn’t much difference in meaning between the two words. But I will say that that is how scientists speak, never presuming the know everything or sounding too authoritarian.
North, It is part of the article recommending the use of icosapent ethyl for PAD.
Sleven,
Nuke, I think your missing the importance of the recommendation. The article stated that icosapent ethyl "should" receive reimbursement soon. These are people who have better insight into the reimbursement process in France. Better insight than any of us. More importantly it's a recommendation for clinical use. When physicians are recommending that a product be used, it puts pressure on the reimbursement committee.
Sleven,
Is the emphasized portion of post your opinion, or actually part of the quote(quotation marks misplaced)?
Thanks N7; I hate throwing water on the campfire, but the Conclusion uses the word “might” versus “will.” We all know Vascepa is efficacious, these Frenchies leave the reader hanging.
Have to agree Kiwi. Hopefully “soon” is soon.
Great research as always. Hopefully, this helps influence/accelerate a reimbursement resubmission/decision
Thanks, sleven. That update from France should help remuneration there.
In hindsight the old managment should have just sold the company when denners proxy started. Probably could have gotten 5 or 6 a share. Now I doubt denner could even get 1.50 a share do sell this POS. He has ruined the company beyond belief.
All that did was make money for the generics. Now the company is on life support and denner has no answers at all. AMRN is one Italy rejection away from being finished for good. Just sad.
BBI, as I said, this was one tiny snippet from a very lengthy article (nearly 100 pages). There’s like 4 pages of disclaimers.
Well that's unfortunate, if not tragic, because they're, in essence, offering opinion that we laugh at when we hear it from our doctors: "Oh, just take a fish oil supplement. It's cheaper and it does the same thing as Vascepa."
Also, shouldn't they have a disclaimer in any article mentioning supplements to explain that supplements are not FDA regulated and may not contain what their label says is inside the bottle?
6 years ago today, RI results were released. Without a doubt the biggest screw-up in biotech history. Wildly successful trial results lead to a company on life support. I really have no words. Just glad I unloaded the bulk of my shares before it got this bad. As cheap as it is, the risk of further downside movement is real.
Yup, it’s unfortunate.
BBI, no, ConsumerLabs is legit.
I have subscribed to it for years. Their analysis is very neutral and balanced. In fact, they take down a lot of supplement companies.
Having said that, I don’t always think their scientific analysis is thorough enough. But I am sure they have limitations on how much they spend on research, etc.
The article/research on fish oil is pretty good. They do use scientific studies to back up their analysis. And a lot of it is very good. What I quoted was just a snippet of the larger research.
Is ConsumerLab.com run by the supplement industry, perhaps masquerading as a legitimate testing source when it's actually just a billboard for useless supplements? This is the kind of stuff that causes so many doctors, even cardiologists, to tell their patients to just take a fish oil supplement rather than Vascepa. Doctors read this and think it's a scientific fact: Some supplements have similarly high amounts and concentrations of EPA and DHA as found in prescription omega-3 drugs like Vascepa and Lovaza, but at lower cost than these brand-name medications.
Makes it seem like all the benefits Vascepa provides are just as easily delivered by your over-the-counter bottle of fish oil supplements.
However, (comma) A post hoc analysis that excluded patients who failed to have an increase in EPA levels in the treatment arm and those who had a large increase in EPA levels in the control arm demonstrated a significant advantage for icosapent ethyl on the primary composite endpoint (HR 0.725; 95% CI 0.553-0.951).
In other words, because of the open label, there appears to have been some cheating on the protocol and a large number of dropouts that when accounted for make the PEP Stat-Sig.
https://www.tctmd.com/news/respect-epa-missed-primary-endpoint-hints-benefit-icosapent-ethyl
About to hit another 52 week low with nothing from management. Very disappointing
Saw this unfortunate update in ConsumerLab.com. I don't think they are interpreting the RESPECT trial correctly. They are ignoring the fact that results were positive, just not statistically significant.
https://www.consumerlab.com/reviews/fish-oil-supplements-review/omega3/#epa-plus-statins
JRoon, The remark was not meant to be "snarky". Earlier today you made comments about insurance formularies without understanding that they are controlled by the pharmacy benefit managers. Now you are addressing preliminary injunctive relief without understanding the requirements for a grant. I don't know if Amarin would make That request. It's a few jumps forward. En Banc request. Return to district court. ECT.... Rulings at this point have opened the other generic companies to litigation that can go beyond the pleading stage. If Amarin would request and receive injunctive relief, it would have a profound effect on the other generic companies. Check the requirements for injunctive relief.
I actually have explained this before.
Sleven,
Thanks for your top notch analysis Sleven.
Rather than snarky remarks, you could give your opinion on how an injunction against Hikma would shut down all 7 generics.
JRoon, Your thought process is impressively linear.
Sleven,
Ram, an injunction would only impact Hikma. There would be 6 more generics to fill the gap.
Orbapu, thanks for posting. I know that at the top of the article there is a disclaimer stating that it is the opinion of the author but I don’t see anyone rebutting the claims made. Scum those PBMs - and of course that makes sense because they are the creation of insurance companies in their current. Had some time since port and shore excursion for tomorrow cancelled because of tropical storm John. You guys steer this board better than our captain as it has been rocky today.
O. thx, good article
Kiwi
C'mon Sarissa.......do it!
Denner/Sarissa could take 20% of he float off the market if they did their BB at these levels.
PBM’s are a scheme to circumvent profit caps set by the Affordable Health Care Act. PBM’s aren’t profit capped.
https://thehill.com/opinion/healthcare/4768725-drug-prices-pbm-rebates/
Kiwi, Thanks. I have read that information before. It's useful but vague.
Sleven,
Whats on the table in PBM negotiations ?
Amarin would need to have some indication of legal progress (well beyond CAFC giving them back their day in court) before any injunction is to be considered. Long ways down the road, and so far, not something Amarin is publicly calling for.
Some sort of injunction Rose would be a beautiful thing..... we'd jump to $10 on that news.
I have never seen a formulary that states ‘we will drug ABC only from XYZ manufacturer. Maybe this is communicated to the pharmacy when filling the script - as to which manufacturer’s drug is permitted but I have never seen that. If a person, for instance has say Aetna insurance with CVS Caremark PBM there are still a myriad of pharmacies that the insured can bring their script to be filled. Odds would say that there would be various manufacturers of the drug from which the various pharmacies would fill the script. Like I said I have received GV from multiple different manufacturers. Only time will tell if I still will continue to see that variety. There must be a reason Amazon is holding off introducing an AG (other than the one we have heard about worrying that it could impact negotiations in the EU or ROW) so it could be that you are absolutely correct about the fact that an AG would be useless. Time will tell. There have been posts here with links to stories about how successful other drug companies have been with their AGs so I find this an intriguing question. Best scenario, though, would be to gain some legal advantage and some sort of injunction against the Generics opening up the US market again for us.
I also heard from CNBC Squawk Box this morning that neither of the presidential candidates want FTC to have this much power to go after companies and Lina Khan's days are numbered. These corporations know how to handle and cover up the findings. What a sad state we are in.
SO much hope, so much pain, so little insight. The Fat lady is beginning to sing. Momma makin that pink sheet pudding. 57 pennies and yet its a great stock to buy !! ANOTHER BUYING OPPORTUNITY RIGHT !!
JRoon, I don't know enough about that to have an opinion. I'm not sure what's on the table during a PBM negotiation.
Sleven,
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