[DMC8]

PUBLISHED 06 December 2024
https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1503704/pdf

[DMC8]

06 December 2024
https://link.springer.com/article/10.1186/s12937-024-01051-y

[Whalatane]

Raggy. IMHO theres a huge movement of $ into any Co's that are demonstrating the use of AI to increase productivity / save costs / get an edge on the competition .
You see it in the DOCU earnings report ...how they have integrated ChatGPT into their programs which saves significant time / labor . In SOUN to enable accurate voice activated orders and reduce labor coast . In APP. e commerce software which is eating into Meta's business .And of course in PLTR's applications . The DOGE is probably going to be great for PLTR ...which I've owned since May 2023
The $ into this area is accelerating . Vol in SOUN has been over the top in the last couple of days.

I was surprised by RGTI that U mentioned . I looked at it but figured it wasn't ready for prime time ...definitely got that wrong.

I don't see any near term reason to invest in AMRN . I'm far more interested in ( and own except for DOCU ) the stocks mentioned above for the reasons outlined .
I'm glad you shared your ideas with this board and hopefully some acted on them
Good luck
Kiwi

[oneragman]

Kiwi, happy for those who checked them out. Still have PLTR as my biggest position and it had another great day. It probably goes into the NASDAQ 100(QQQ) next Friday. 🚀 I still have shares of AMRN, but it seems to be getting left behind by this market. There a world of options to invest in. I certainly don't see bankruptcy, but it's definitely dead money which is not what anyone wants in a hot market.

[north40000]

DAR53, timeline and outcome/result of suit are currently unknown. Fastest positive results will be achieved, IMO, if each Amarin shareholder with Amarin $$$ losses in their portfolio(s) would write their respective U.S. Senators a letter, asking them 1) to correspond with the Chair of the FTC, and urging those Senators 2) to support and vote in favor of the 2 currently pending Senate Bills that involve an investigation of Pharmacy Benefit Managers(PBMs) and Insurance companies( many own PBMs), and their role in increased drug prices in the United States vis a vis drug prices in foreign nations/markets.

1) the current FTC has a current, July 2024 faq release excoriating the pharmaceutical industry for increased drug prices( the generics are part of that industry). The FTC has yet to answer the Express Scripts and CVS/Caremark Complaint filed in the W.D. Missouri. In a transition political period, both Democrat and Republican Senators will/should intensely support investigations of hints/evidence of fraud occurring anywhere in government, including the Federal Judiciary. Asking the FTC to investigate/subpoena pertinent documents from Hikma and Dr. Reddy files relating, inter Alia, to correspondence and telephone calls of  any kind that resulted in their joint post trial brief in the Nevada Federal Court could prove fruitful for reasons we shareholders explained in our Petition for Writ of Certiorari in the Supreme Court, denied without opinion on the fraud issue.  Letters from Senators asking the FTC( and/or DOJ, SEC) to initiate an investigation are likely to yield fast results, faster than SH's letters, IMO.

Time for dinner.

[DMC8]

https://nutritionj.biomedcentral.com/articles/10.1186/s12937-024-01051-y

[rosemountbomber]

Was going to reply to Seve to say that while I know close to ZERO when it comes to negotiating with EU countries for drug reimbursement, it seems to me that wrt all those countries mentioned, the applications were put in before Denner gained control. Of course, I don't know about the process after that and what the company additionally submitted and also whether they were confined by the initial application. I was thinking along the lines of finding out if and whether Denner-led Amarin could have argued for that "Netflix" type of arrangement that he mentioned during the conflict with prior management phase. As I was searching for info online about that I came across an old story but it tickled my brain into a couple of thoughts. Here is the link to the old story: https://www.biospace.com/amarin-shares-plunge-following-ruling-in-vascepa-patent-lawsuit, but let me mention the two thoughts that it triggered.

Firstly, the story mentions the stock dropping 70% in premarket the morning after the Du decision - yeah we know it went to $4. Thinking about it today, that signals that the whole investing world realized that even though the ONLY patents that were invalidated (and the ONLY indication the generics could market to) were for the Marine indication, that Amarin's major indication (CVD) would be decimated. Common knowledge, yet no one could stop it. Does anyone think that in these last 4 1/2 years if the only scripts that were filled were for VH trigs (over 500) that our stock price wouldn't be significantly higher than $4?

Secondly, some of the things Thero is quoted as saying right after the ruling ring hollow:

In a statement issued following the ruling, Amarin said it “strongly disagrees” with the ruling and will “vigorously pursue all available remedies,” which could include an appeal of the court’s decision. Amarin Chief Executive Officer John Thero said Amarin could also seek preliminary injunction pending that appeal against any generics that could be approved by the FDA and launched prior to the day in court. Thero went on to note that the company will take all legal actions necessary to “defend and protect” the company’s intellectual property...................We believe we are favorably situated to obtain an injunction against generic launch pending appeal, subject to our posting a bond to secure generics’ lost profits in the event that generics prevail on appeal,” Thero said in a statement.

I think most of us would agree that Amarin did NOT “vigorously pursue all available remedies,” as majorly evidenced by them not supporting Marjac/North's efforts. Also, I can't remember so maybe someone can refresh my memory but did they seek injunctions as Thero outlined?

I know all this is about stuff like water under the bridge, but it struck me that immediately after the decision the entire world basically knew that the Generics would steal the CV indication for V. A corrupt system.

I keep thinking that when I watch an NFL game sometimes when a referee screws up a call against one team on the next play it is as if he tries to even it up and call one on the other team. I am always hoping that the pendulum finally swings the other way and we start benefitting from the infringement case against Hikma. I realize that will unfortunately take some time.

[seve333]

Its amazing Denner has been around now for 20 months and still no approvals from the big three. All he has really gotten was Spain. They are basically selling in two Europe markets and that is it. Still not Italy even though they claimed it was coming. Hard to believe anything they say anymore.

[rosemountbomber]

You can say that again. I dipped my toes into QBTS and QUBT the following day but didn't feel good or confident about picking up any Rigetti.

[CaptBeer]

Continued whispers from The Dark Side: This is way above my paygrade but herein Dr. Pablo Corral states”

“On the basis of demonstrated beneficial ASCVD outcomes, icosapent ethyl is recommended for patients with elevated triglyceride levels and ASCVD, as an alternative to EPA/DHA combinations.”

“Biosynthesis and Metabolism of ApoB-Containing Lipoproteins”

https://www.annualreviews.org/content/journals/10.1146/annurev-nutr-062222-020716;jsessionid=JbWBgk8ykG3CkvoMw6sLt9IZ7W9Jwde5xaYxfqMv.annurevlive-10-241-10-91#right-ref-B13

[Whalatane]

Raggy ... Congrats re

My biggest position in Quantum is IONQ, another big winner for me, followed by QBTS, QUBT and RGTI.

Anyone on this AMRN board that followed you into these on the date ( Nov 29 th ) you posted this ...is one happy camper today
Thx for sharing your ideas
Kiwi

[north40000]

The Congress and Federal Government could/should enact legislation to provide funds to Amarin to help it reduce the risk of Americans from dying from CVDs with Vascepa product(s), much like Congress has provided funds to Cancer Drug companies, Big Tech and Small Tech for various programs those companies are engaged in. 

Big Tech itself could invest in or provide funds to Amarin to help all Americans reduce the risk of death from CVDs. Recall that an American dies from CVD elements---heart attack or stroke---every 38-40 seconds, more often than from all cancers combined. 

Professor Nestle, Department of Nutrition at Columbia University, proposed legislation that would help fund the food industry to provide better diets to U.S. citizens. She appeared on CNBC-TV in the last 45 minutes today, about 11:30 am.

[the_kube]

Why not turn this into a class action?

[seve333]

I can always buy back in as I expect the price to remain low for awhile. But I said I would give Denner 1.5 years and I did but I was beyond disappointed in him and what he brought to the table. CEO's quitting, no buyback, etc. So I just felt it better to move 2/3rds of it to stocks I feel have much better promise going forward. So far on one I made up for all my losses on this stock. The biggest mistake I ever made was not selling after the judge destroyed this company. I thought Europe would be a good market to make up for it but boy was I wrong on that also. I also certainly will not count on any court cases those will take years at a minimum.

[DAR53]

north40000, you are one impressive individual. My hat goes off to you and your untiring and tenacious efforts to right a wrong. Do you have any estimate of your timeline and ultimately when you would expect an outcome of your suit?

Thanks

[north40000]

An employment Act for lawyers? Tie up Hikma, TEVA, Dr. Reddy in knots? I plan to sue them all in local county court in Virginia and in the federal District Court here in Virginia to recover our losses in value of Amarin stock price beginning with date of Nevada District Court decision. Our present losses exceed $180,000 which is greater than the Federal jurisdiction $$$amount. The cause of our loss can be traced directly to the collusive, culpable, deception that Hikma and Dr. Reddy engaged in misleading, via their post trial brief in the Nevada District Court, that Court to declare the 6 patents involved in that patent infringement suit invalid under 35 U.S.C. 103. The fraud on that Nevada Court is detailed in the Petition for writ of Certiorari we shareholders filed in the Supreme Court, which I will incorporate by reference, that was denied without opinion for our lack of standing like the CAFC ruled. Imagine the consternation of the above generics if all SHs of Amarin stock around the 50 U.S. states were to file similar suits in their respective states. Remember Hazel-Atlas Supreme Court case that supports the Federal Case, and the recent CAFC opinion observations that 1) Hikma has no FDA-approved ANDA to treat CVDs, and 2) that there is no evidence that shows the Hikma product to be therapeutic equivalent to Vascepa.

[Jasbg]

I don't suspect this local Nevada Judge will ever understand the damage she has done - here.

Vascepa were on the road to becoming a real 'well deserved success' - when she totally pulled the rug under the small bio company,
------------------------

What does this Generic copy mean for say eg Teva - they sell +3600 different pharma products - have 37.000 employees !

https://www.tevapharm.com/our-company/teva-facts-figures/
--------------------------

Getting ever more difficult to understand the "value" of Amarin ! The company now hold more than $ 100 million more in cash than total value of stocks !

https://finance.yahoo.com/quote/AMRN/key-statistics/

[rosemountbomber]

Scroll down that page and look at so many of those patents that have become utterly useless. I hope they get their patent application fees returned to them.

[Jasbg]

There are now 8 generics versions of Vascepa on the US market - 3 of them make both 1 - and 0.5 gram versions.

https://www.drugs.com/availability/generic-vascepa.html

Haven't seen much of the AG debate lately. If nothing else it ought to make it easier for 'everyone' to get the Brand version - you would think.
----------------------------------------

icosapent ethyl capsule;oral

Manufacturer: APOTEX
Approval date: June 30, 2021
Strength(s): 1GM [AB]
Manufacturer: ASCENT PHARMS INC
Approval date: December 7, 2023
Strength(s): 500MG [AB]
Manufacturer: ASCENT PHARMS INC
Approval date: February 16, 2024
Strength(s): 1GM [AB]
Manufacturer: DR REDDYS
Approval date: August 7, 2020
Strength(s): 1GM [AB]
Manufacturer: DR REDDYS
Approval date: March 8, 2023
Strength(s): 500MG [AB]
Manufacturer: HIKMA
Approval date: May 21, 2020
Strength(s): 1GM [AB]
Manufacturer: HIKMA
Approval date: March 8, 2023
Strength(s): 500MG [AB]
Manufacturer: HUMANWELL PURACAP
Approval date: December 22, 2023
Strength(s): 1GM [AB], 500MG [AB]
Manufacturer: STRIDES PHARMA
Approval date: September 22, 2023
Strength(s): 1GM [AB], 500MG [AB]
Manufacturer: TEVA PHARMS USA
Approval date: September 11, 2020
Strength(s): 1GM [AB], 500MG [AB]
Manufacturer: ZYDUS LIFESCIENCES
Approval date: April 20, 2023
Strength(s): 1GM [AB], 500MG [AB]

[ramfan60]

Hey Nuke..... they do allow onside kicks but you have announce your intention........ so they don't allow "surprise" onside kicks.

[Nukemtiltheyglow]

(OT) I'm watching Thursday night football, Packers @ Lions. I just noticed something really stupid :D/ The new kickoff rules doesn't allow for on-side kicks anymore? That's supposed to make games more exciting? 

[rosemountbomber]

Dar, appreciate being called steadfast and lumped in with those heavyweights. We are all in this together. And, you are right about the fear of jumping positions. It would be real easy to dump and Amarin and you could easily find a very, very safe dividend stock, but you will never make back your money that way. To find something that has the chance to give you a 10x return, to make up lost money here, would mean getting into something that by definition would be risky and could backfire stupendously. We know what we have here.

[DAR53]

seve, you might have done the right thing and part of my fear was jumping positions and then that being a mistake and it going south. So, I have averaged my cost basis downward to a place where when / if it moves to 5 or 10, I will be in a good place. If it doesn't, I'll survive just fine.
But I agree that it has been extremely disappointing since Sarissa got involved, but I still believe it is better than what we had before. JMO
We currently don't have the pumpers that were here before, but we have the bashers and then the steadfast like CaptBeer, North40000, Sleven, RMB, Lizzy, Nukem, CBB and a few others that I respect their opinions and positive efforts for this company. That's why I hold my positions and buy more if I think positive news is ahead.
GL

[seve333]

I have owned this stock for many ears and simply got tired of waiting on it the last few years . Given where it sits almost two years into Denner I felt it time to move alot of my position to a few other bios I have which many many irons in the fire in the next six months or less . Maybe I will end up regretting it but I just don't see this stock doing much of anything until they can show some significant revenue outside the usa, which is probably at least a year away imo. Probably the last two straws for me was losing the bog usa contract and backing out of the buyback everyone expected was coming. I can believe in the drug all I want but if they cannot sell it outside the usa it does not matter the stock won't do anything. And I have also been very unimpressed with Denner and especially by pumping the buyback simply to drive the stock price up but never really intending to do the buyback.

[DAR53]

seve333, thanks for the response. I know AMRN has not had much or any positive news as of recent and the investor conference was simply a regurgitation of old news. I have not sold any shares and continue on with the belief that this will get turned around in 2025 and early 26. There are several things that should / could occur in the next few months.
Italy
France
Favorable verdict on sending the Hikma case to a jury trial. I know it will play out over 2-3 years, but just the case being remanded back to a jury trial is positive and hopefully would be seen as such by the market.
Exponential Ramp-up in Europe and China
Updated Vasepa product for US
Possible Vasepa generic for US (although I don't see a benefit) as the product / price is still the product / price. Not sure if simply the word generic wins the battle.
BB
Sarrisa adding shares
I for one don't want to see a RS. What would that look like? 1 for 3, 5, 10?
Anyway, just spitballing some of the things we know are options or being worked as sit in the dark with no communications from Amarin or Sarissa.
GLTA

[Skipperdog11]

no arguments here rmb. The biggest shock going forward was a complete "deer in the headlights" response after Du from JT and the boys. Also, the most passive, do the bare minimum, legal response going forward that is and has been mind blowing. Deciding to not put forth an organized multi-front complex legal effort has sealed the fate of the US market. No ITC? Only one manufacturer? Too late to make any meaningful progress on this front. Hope the row has potential.

[rosemountbomber]

So it appear that although it is oil based, it is not the oil that is the active ingredient that does the magic. It is an anesthetic called ropivacaine.

[rosemountbomber]

I really hate going back to the Du decision,

I have been scolded in the past for bringing that up too many times, but there is no question that that was the most impactful moment for Amarin's business going forward. It could have been so much different otherwise. We, I guess, will never know if a settlement could have been reached (and I am not even considering all the trial mistakes made by Amarin's legal team). Don't know if the defendants would never have accepted any kind of settlement and were dead set on throwing the dice by going to trial, or whether their demands seemed to high for management. If the latter, it is clear with what has happened to the business since, that no matter how high a monetary settlement they were seeking, it would have been worth it for us.

[Nukemtiltheyglow]

(OT) I'm not posting PRFX as a stock recommendation. However, their post-operative pain relieving scheme is an oil based solution that is used during surgical procedures. It is non-opioid based. I'm curious as to the oil they use? Proprietary perhaps? Could it be EPA? We all know how anti-inflammatory Vascepa is... just curious? God, don't let it be mineral oil....we've all seen the results of that? Herper and Fartstain will get a hold of that one.
https://finance.yahoo.com/quote/PRFX/profile/

[seve333]

Yep still own 30k I sold about 50k in the last few months and put it in other stocks with much better potential. After almost two years of not seeing the denner master plan I needed to put it where i could actually make some money. Maybe someday I will get my money back on the remaining 30k but I highly doubt it. I had alot of hope in denner but after almost two years I can now see he is no different than the old management. Same old same old.

[JRoon71]

Great point, PL. And forgive me for getting personal, because I don't like to, but Denner has some significant personal financial commitments that he may be having to deal with as well, which is why some of the assets have gone away. Either way, you are right, the existing investments become disproportionately larger. Currently, if AMRN's SP were back at what it cost Denner originally, it would be his #1 or #2 holding.

[JRoon71]

Chrome, obviously I hope you are right.
The BIG advantage we have is safety. Virtually no side-effects, and tons of upside (even well beyond the indications). As I have stated before, nearly everyone in the world would benefit from increased EPA in their body.

The challenge is convincing the world that this is needed.

I really hate going back to the Du decision, but we had some massive tailwinds on the heels of R-It, and this all would have looked very different if the U.S. rollout had not been derailed, for so many reasons.

[ProLiberty]

I don't know this but speculate that Sarissa/Denner, having had a number of poor outcomes and mediocre performance, are likely to be seeing some investor assets departing. A hint of this might be the near full elimination of what was once their largest position Biogen, yet that significant amount of capital has not been used (I don't believe) to add a large new position or add meaningfully to a current name. The size of Amarin in the portfolio could go up just from asset decline, and could easily double in size again on a jump back to $1. This might, and I emphasize might, be a factor in the lack of adding.

[Chromosome]

JRoon, that is largely true as it takes time to develop the market. I would say statins bucked the trend. From my experience at AZ with Lokelma (hyperkalemia), success hinged on converting the market from acute, ambulatory setting to chronic use to keep potassium levels in range, the premise being that this would prevent CKD and have cardiovascular benefits. This would have gotten us to a 1 billion revenue at peak. Last I checked they were running around 400 million and expected to get to 700-800 million by 2029. So yes, it takes time. Ironically, I think single payer countries probably appreciate prevention more than the US since governments plan for the longer term.

[north40000]

Compare those links relating to Amarin with this link to Anavex Evercore ISI HealthCONx Conference presentation yesterday, 12/04/2024 at 3:25 pm:

www.anavex.com 

Replay of CEO's fireside chat presentation should be available today.

[JRoon71]

This right here is the challenge we face:

The science works, but it is more preventive vs curative which strips it of the acute wow factor needed to move the needle with wallstreet, consumers, doctors, EU countries, and prospective BP buyers.

Unless a BP is convinced that they can convince thousands of docs, and millions of people to take Vascepa for life, I'm not sure what the angle will be.

This is sort of the realization I have come to, as I have watched the country rollouts, the reaction by the media, docs, specialists, etc. There is almost nobody saying WOW! this drug is amazing!

Most of the literature I read from cardio specialists (even the very supportive ones) basically look at Vascepa as an "add-on", sort of a "well we can try this, too" solution.

So, unless some large group of docs have an epiphany (or we see some serious positive RW data), I think the expansion is going to be very, very slow.

[north40000]

CNBC-TV just showed 2 face pictures of alleged killer without mask. 11:30-11:40 am.