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Yes, it’s a screaming buy. I saw no bad news in the conference call. Some ordinary bumps in the road with the merger. Dilution/debt isn’t problematic unless they waste the money instead of profitably investing it.
Even the downturn in the EV sector works to Exro’s advantage, because it reflects consumer desire for enhancement of the kind that Exro provides.
Am I missing something?
It’s good to see you in apparent good health.
In Reduce It 4 grams of Vascepa raised the average American EPA level to about 90% of the Japanese EPA level,
The active arm of RI only had slightly increased A-Fib, and did not have more strokes. Strokes are the reason people worry about A-Fib. Dr. Bhatt said even the subjects with A-Fib were better off taking V. I have no problem with bleeding or bruising. Analyses of RI and JELIS data confirm increased risk reduction for higher EPA levels, which were attained for the trial subjects with lower blood volume and more fish in their diet. The data clearly show that larger doses of EPA would yield additional benefit.
Your warning about dangers of higher EPA doses is without scientific basis and could kill some of those who heed it. Those on blood thinners should adjust their blood thinner dose appropriately.
Where are people chatting about EXROF these days, and what caused the huge price drop the last few days? Bear raid?
I couldn’t agree more.
The optimal dose of Vascepa was not very thoroughly researched. Marine tried 2 and 4 grams per day. They saw more TG reduction with 4 compared to 2, and estimated that 4 would bring Americans close to the EPA level of Japanese, who eat a lot of seafood and have high EPA and good cardiac health. So, they went with 4 g.
But, the true optimal dose depends on body weight, sex (more for males), age (more for older). Probably also more for those with more inflammation due to other medical conditions. It turned out 4 g didn’t bring Americans to the Japanese level, and I see no reason to be sure more EPA wouldn’t make the Japanese even healthier. And, little downside to higher doses other than expense. I take 4 to 6 grams of OTC EPA in addition to 4 Vascepa capsules. (I’m age 68 male with some chronic inflammation.)
No question about it. There never really was a valid reason to doubt it. Strong benefit for people at risk largely independent of TGs, LDL, statin use, or prior disease. EPA/AA ratio has long been recognized as a strong indicator of risk. The case has grown even stronger with additional analysis the last few years.
North - I’m curious whether you think Judge Du would be able to do anything at this point, if she were to see the light and change her mind.
Please give me a call at your convenience, I’m having trouble finding your contact info. We’re a few years overdue getting together.
Charlie “Chas” Lyon
703-509-3273
Does anyone know about how Vascepa-friendly Blue Cross Blue Shield and/or Cigna insurance is?
I remain extremely enthusiastic about Vascepa, which has great life-saving and life-enhancing benefits for people far beyond the label (pretty much anyone at elevated risk who's not allergic, even with a-fib according to Dr. Bhatt), and long-term RRR greater than reported after the start-up period, that's somewhere between a few months and a year or two depending on risk level (higher risk = less delay). I try to spread the word. The dosage was never really optimized. More very probably gives more benefit, especially for those at higher risk and larger blood volume. I take 4g and add a bit more pretty pure OTC EPA.
Less excited from an investment perspective. Still have a small holding mostly for sentiment. I followed JL into EXROF. He said he sold his EXROF, but I'm still very, very bullish on it long term as a speculative play. It could start moving soon, or it could take a while. Less vulnerable to court corruption than AMRN was, beaten down with market and very recent money raise. Bullish on overall market too.
I'm making a proposal to EXAS to improve their algorithms for Cologuard and a new blood test for multiple cancers. Got a slight nibble of interest but not yet hooked. Working hard on that. No question I can make significant improvement, but I need data to refine and prove and hard to negotiate when I can't give away the secret recipe if I want to get paid, which I do.
I check in here from time to time. Amarin, Vascepa, and this board are special to me. I would like to do a paper to optimize V dose based on meta-analysis. I have ideas how to do it, but would need co-authors & funding, and that would be a long shot.
The JELIS 19% RRR is understated several ways. The EPA dose was only 1.8g instead of 4g for Vascepa, the subjects were lower risk due to weighted more heavily female and, more importantly, much higher baseline EPA level due to more fish in diet. RRR strongly tends to be higher for higher risk subjects. Also, JELIS subjects had lower TG levels. The high TG subgroup had RRR of 53% (although the subgroup was not large, which lowers the precision of that result).
All EPA clinical trials underestimate RRR due to their limited length and the ~1 year delay before CV protection fully kicks in, by an approximate factor of L/(L-1), where L is the length of the trial (average duration of subject participation) in years.
Is this the full Stat article? Authors? Title and date?
See page 5
Vascepa note 6/30/22
You can be very proud of what you did, standing up for what is right. Many thanks to you, and to North. It is important to have the facts put on record in the way that you did.
I'm curious if the generic has a stinky fishy smell when cut open, as reported in the amateur review video. Vascepa does not smell fishy. I believe Amarin has proprietary manufacturing technology, including for encapsulating. Apparently that has an impact on quality. Oxidation has unhealthy effects.
marjac - I respect your modesty, but you are very far from nothing.
No matter what the news is on Monday, you can be proud of what you've accomplished. You got the facts on the record including what most people would consider tantamount to a confession, when the generic's counsel declined when a judge offered him the opportunity to comment about the clear accusations of fraud and lack of factual basis for obviousness.
Thanks for all you've done.
Thanks
Here's a link to an updated draft of my note about Vascepa (minor recent edits, including added link to the paper from the Bhatt crew about substantial benefit for subjects without established CVD, which is off-label, an important result):
updated Vascepa note
Ziploc - (or anyone in contact with JL) - Would you please ask JL to give me a call?
In the real world, I'm Charlie Lyon, cell 703-509-3273
An unverified non-scientific comparison in late 2020 reported a generic had earlier expiration date than genuine Vascepa (Sept 2022 vs Feb 2024) and a fishy smell Vascepa didn’t have, consistent with partial oxidation (spoilage), which is undesirable.
They seemed to report significant information without lengthy delay.
Probably not. She probably thought granting generic access early would help the poor by lowering prices. In reality, she mostly aborted the US rollout and made a huge disincentive to innovation generally that will have untold effects for many years. Trying to keep that note non-controversial for wide circulation. The intent is to spread the word to save lives, to encourage wider labels overseas and more off-label in US, and to encourage the DAW (dispense as written) movement in the US. When I finish honing it, I will circulate it more widely.
The first clue about the Patent Pilot Program that I saw was a fluffy article about Du that came out after her ruling. She was quoted commenting in it that she enjoyed learning about "fish oil". I wasn't prompt looking at the article in detail, and didn't do additional research on the PPP until long after. BTW, the judicial system can provide competent advisors on various specialized topics, but that seems to be very rarely taken advantage of.
We had, essentially, an untrained novice getting her OJT on a case far out of her expertise with billions of dollars and many thousands (maybe millions, over a period of years) of lives at stake. No supervision or expert advice or review and a highly unreliable and ineffective appeal process. I assume someone who re-directed the case to Du probably thought it was such an obvious run of the mill frivolous challenge of a valuable patent that even a beginner could handle it (by upholding the longstanding patent).
https://www.nvbar.org/wp-content/uploads/NevadaLawyer_May2020_Du-Trutanich-Profiles.pdf
Absolutely. The current draft was written before I had that link. I did link Marjac's rule 60 filing. I'm currently collecting suggested changes, and later will circulate the final draft more widely.
I was just thinking we should do that sometime. You were invited to dinner at our house with other DC area Amarin investors from the IHub board, on the eve of the release of the full RI results years ago. As I recall you couldn't attend because you went to Chicago to be there in person while several of us got together for dinner and watched the Amarin video presentation that evening. I recall serving scallops, and LouieBluie brought some wonderful wine and beautiful flowers too if I recall correctly.
I have some imminent travel coming up but we definitely should get together soon.
Best wishes,
C
If you have insurance that covers Vascepa and a doctor who will prescribe it (off label if necessary), you'd be better off with genuine Vascepa. It's worth changing insurance and/or doctors IMO. It's not just which fish that matters, but steps taken to preserve freshness. The way to test for fishy smell, a sign of oxidation (spoilage), which is common for supplements and even generics, is to cut a capsule open before sniffing.
Thanks Ziploc - I still have a few AMRN shares, still take Vascepa, and urge my friends and anyone who will listen to consider taking it after consulting with their doctor.
Hard to believe how things turned out. I expected a fairer, more rational outcome. I was not fully aware of the Patent Pilot Program and Du's participation in it until fairly recently. I give some links about that in my summary. Hard to believe this would be allowed to happen and go uncorrected in the US. We're in uncharted territory these days.
BTW, the Patent Pilot Program was tried for 10 years and then allowed to expire, about 6 months after the Vascepa case. But, Du, who is now the lead judge in her district, liked the program so she's on record saying she'll continue it in her district despite the program's cancellation nationally.
Giving inexperienced judges extra patent cases for OJT isn't crazy, but a brand new student driver shouldn't be out on the streets without an instructor, and shouldn't start off at the Indy 500 first thing. Her indefensible ruling will probably cost over a million lives over a period of years IMO.
Link to a downloadable pdf file of my note about Vascepa.
https://drive.google.com/file/d/1toizRozuZTVb5DWHdDr4I21Ux08dTjCP/view?usp=sharing
Here's a link to a summary I wrote about Vascepa and its benefits, including for those beyond the current label. It also makes the case for marking prescriptions DAW (dispense as written, no generic). I welcome any feedback.
Vascepa note
http://twitdoc.com/BMF1
Question for the group - I've been doing some more thinking about Vascepa, and what additional case can be made for expanding its use beyond the FDA label and for expecting more long term CVD risk reduction than has reported to date from RI. I have a clear memory of seeing a chart in a JELIS subgroup analysis paper that showed curves of risk reduction vs plasma EPA level for various subgroups (old, young, male, female). I remember writing a short note about it, commenting that the optimal V dose (for near maximum benefit without wasting V) was whatever it took to get to the plasma EPA level high enough to have near-maximum risk reduction. That dose was clearly higher for older subjects and for males.
I've been trying to find the paper with that graph, and can't find it, or the note I wrote about it, which presumably gave a link or reference for the paper. If anyone happens to be able to point me to either the paper or my post about it, I'd be grateful. Not sure what year it was. One of my posts on August 30, 2020 mentioned I had written it a while before that.
My current efforts extend my analysis for a letter I submitted to the FDA in December, 2019 advocating for a broad Vascepa label (link in post 231944). I hope to build a case that can be used to convince doctors to prescribe more widely, in the US and elsewhere.
Also, does anyone have recent articles (last year or two) by Herper and/or Fuerstein about Amarin or Vascepa? I refuse to subscribe to Stat, and want to know what they've been up to.
Thanks
Marjac -
Congratulations for your great performance. Thanks for all the hard work.
The primary source for attempting to predict RI results, independent of the ridiculous mineral oil issue, is JELIS. There are different ways to approach that, but the key factors are indisputable. JELIS got 19% with a smaller dose on a healthier population with a much higher background EPA level. I did an analysis years ago, before the RI results were known, and arrived at expected results substantially higher than the 25% that was reported (closer to what was observed when additional events were included, after the primary events).
The plaque volume studies also demonstrated substantial benefit with no mineral oil.
Agree with your low opinion of that recent study. I doubt it gets traction with key opinion leaders.
Beyond ridiculous. For those talking of the need for a second major CVD trial, RI was the second trial. JELIS was the first.
JL - I like bargains too. You were years ahead of the herd on AMRN, and patiently made believers of a bunch of us, for which we're grateful. I recall your AMRN buy at about $0.80, on the way to $23+. (Should have gone even higher, but that's another story. If they made it into a movie, I'd watch.)
It gets my attention when you're excited about a stock. I followed you into BNGO. Added today at $4.99 and thinking about adding more. A substantially better product for a much lower price in an important market seems like a winning combination. Got some EXROF too. Both have exciting innovations.
Hope you're well and getting some golf in.
I agree success with en banc seems like it would be unusual, but this is an extremely unusual case. I'm not saying success there is likely, but we can hope some judges retain some sense of fairness, decency, and justice under the law. I think this is part of the fundamental transformation of America Obama promised us in a moment of candor days before his election, despite campaigning as a moderate.
For an organization that took over half a year to decide whether to let Amarin include in a DTC advertisement a simple statement of their FDA-approved trial result after it had been thoroughly reviewed and Vascepa approved, the FDA sure is lightning fast (for them) to approve generics who they know are going to violate common decency and fairness and probably the law by selling far beyond their skinny label. Sadly, it's no surprise.
Liberal is one thing. Lately it seems more and more to go past that to radical leftist and even criminal. Not good for anyone, especially the poor who they claim to care about. There will be less innovation and millions will be delayed in learning about Vascepa. There is a death toll associated with that, and it’s not small.
I think of it more as something to toss in as part of an email or print ad or website. I don't see how most of the US sales team continues to exist for long, if the generics take anywhere near as much of the business as the market seems to expect as indicated by the share price reduction.
To try to salvage a bit more from the US market, how about a DAW (dispense as written) campaign? Amarin could send brief messages to doctors appealing to their sense of fairness. It could be an extra line or two at the bottom of a medical journal ad. Point out that, with generics using a loophole to enter the market long before Amarin recoups their development costs, there's inadequate funding to educate doctors and promptly deploy life-saving Vascepa. Generics don't do that, they assume it's already be done. Adding DAW to Vascepa prescriptions would help fund gett the word out, would help preserve the incentives needed for drug dingevelopment generally, and it's just the right thing to do. Patients with insurance would not pay any more.
Just a thought. If 10% of high prescribers did that, seems like it might help a bit.
Agree. Also ludicrous: a single judge without scientific expertise casually invalidating 6 patents worth billions, effectively transferring those billions in part to generics and in part to consumers via presumably reduced prices.
Try post# 295123 (North4000)
sstyles - Thanks for your input. I'm trying to keep count of profession legal opinions. A fair number share your view. Are you an attorney, and, if so, how familiar with appeals of this type? TIA
My understanding of generic threat in Europe:
There's 10 years regulatory protection from approval (presumablu around Jan 2021. I believe EU patents run to about 2033.
There can't be a European version of the Du-bacle because that involved the niche (trigs >500) indication that does not exist in Europe, and there's 10 years of regulatory protection. On top of all that, if by some devilish magic there were a trial, we now have much more info (the statistical paper Bhatt co-authored, etc) and would be able to defend much more effectively.
If something is going to go wrong in Europe, it seems like it would have to be something else besides early generics.
The $13 AMRN share price pre-Du included about a $4 Covid discount reflecting a general market dip that has since rebounded. I believe Europe is worth quite a lot, and US is worth at least something even if the appeal fails, but the market won't fully price Europe in this far in advance, even though approval seems very likely and a Du-like event is impossible in Europe several ways.
I think an appeal failure drops the price, but only briefly because the Europe approval very likely follows soon. I think AMRN would drop, like it fell under $4 after Du, but pretty quick recovered to $7-$8. I think a lot of people would buy an appeal loss dip, so the dip seems likely to be shorter and shallower than might be expected.
Just my opinion, who knows. Amarin keeps coming up with surprises. The science is very strong and keeps getting better. One of these days the share price should benefit appropriately.