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Oh, but you can dispute the stock price. What arbitrary date are you picking.
From Sept. 1, 2022 through Dec. 31, 2023, Amarin's stock price was mostly and consistently below $1.20 with a low of $1.04 in late September. You know the old saying about figures right.
Dar, I think you have summed it quite well.
Kiwi, no it was just a personal mess. Decided to power wash the driveway, so I started what I thought was early, but it took longer than I expected and it was hotter than the dickens. No breeze and nothing but blistering sun. Should have done it after dinner rather than before lunch.
Most of my stocks were like Amarin today - slightly down. Except for one. Management came out and predicted massive revenue over the next few years - AXSM.
There is no question that I got the message that they are in a hurry and realize the clock is ticking. Whether they are able to turn the ship around is the $64,000 question. I am hanging with it, as I believe in the value that the EPA molecule represents.
Yep, maybe Berg did not sound stupendous, but part of that is the situation they are in. He can't lie about the position the company is in. Here is to hoping that the UK conference triggers a healthy amount of V scripts in the UK and the other EU countries start coming around with their reimbursements.
Kiwi, been a rough day today and I am just now trying to catch up on the latests posts here.
Trying to educate myself enough to answer your question, I became rather confused. Your question seemed to indicate that Kaiser HAS ENDED V scripts to their Mitigate CAD patients. But when I look at your post directed to Sleven it doesn't seem say positively that Kaiser has ended V scripts to Mitigate CAD patients. Have they?
If they have, it could simply be kind of a left hand/right hand kind of thing. It is typical of clinical studies to terminate at some point and whatever arm was doing the study is separate from the rest of Kaiser. Or at least that would be my guess.
Correct, they were professional do-nothing board members.
I am the furthest thing from being knowledgeable on technical analysis, but looking at the 6 month chart, I am thinking that it looks a little positive going forward. The stock price (although not continuing its climb) has not crashed and is looking like it wants to head north. But obviously we are always last to find out if anything is happening behind the scenes.
Trading volume rather low.
Hard to find the answer listed but found this where Carlsson says it is mineral oil:
Thanks Kiwi. I had a feeling that there was no futility stop in place for much the same reasons you mentioned.
Reading about your discussion with JRoon about how things are different from 3 years ago, I have these thoughts. Denner first bought Amarin shares 2 years ago somewhere in the 2nd or early 3rd quarter as Sarissa's first report was dated 9/30/2021. So at that time we did not know about the plan for Russia to invade Ukraine nor the ramifications of that towards gas supplies.
But Covid had been here for more than a year and from what I seem to be able to find, it is not only in the last 2 years that getting drug reimbursement in the EU was tough. This seems to highlight some very slow action there dating to before 2021:
https://efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
Sorry if this was already fleshed out but did we ever find out if BRAVE has a futility stop built in or since it is a relatively short trial no?
Kiwi, sorry to hear about your KDNY news. Things like that have happened to me. Very frustrating.
As far as your MD, believe it or not, I actually might agree with his take. Why get jabbed with a needle as there is nothing more they can do. I guess they should still see what is going on though. How else to know whether to dump a treatment.
Take it easy. My day a piece of cake compared to yours.
“I always thought AMRN would be acquired before European price reimbursement negotiations.”
There is no question that that is what should have happened. And even with a potentially obstinate JT asking too much early on (around the time of R-I), if it would not have been for the DuDisaster, I believe a deal would eventually have been struck well before EU reimbursement applications.
What concerns me (and I could easily be wrong) is that the applications for reimbursement are already in in most of the EU countries (at least the big ones). Does that mean that Amarin have very little it can do but simply wait for those drawn out decisions?
Talking about the EU these words popped out: "Whether we can do it alone......."
Expected it to be a household brand but then the DuDisaster happened. I am paraphrasing.
Thanks for posting and reminding us Sleven. Hopefully, Berg and Reilly learn and improve from the tough questioning from Yee at the Jeffries conference.
Not sure if we will glean anything new but hoping.
No argument there. At this moment every bio that I have except for Auphie is green.
Yep, and another example of how so many acquisitions are made around (either before or just after phase 3 results) and long before any drug approvals. It seems BP's appetite is before approval so that they can control and manage rollouts.
Canes, I guess it is hard not to think about it because it was just a monumental pivotal moment in Amarin's business history.
I blame myself for not exiting stage left before the trial got started, but as we have seen for instance with the Dominion v Fox lawsuit, settlements can come even as the trial starts, and I was going by the idea that a settlement was in the best interest of both parties. As we have seen, winning did pretty much jack for the Generics as the level of scripts is minuscule, rather than if they had let Amarin mature the market first.
I too will be interested to hear BBI's answer to your questions?
Thanks FFS. Sounds better to have inflammation of a muscle rather than an artery.
Thanks Duke for clearing that up for me.
Thanks for posting Sleven. I am anxious to hear responses to your question. For some reason, I have read #2 hundred times and I clearly do not understand it.
From Stocktwits. No mention specifically of Vascepa or BRAVE-EPA but a story about the group in Wisconsin who happen to be running the BRAVE-EPA trial:
https://onwisconsin.uwalumni.com/progress-on-alzheimers-disease/
He was either good or lucky with his call on Vioxx and I think that success went to his head.
Thanks Duke. I don't seem to exhibit any of the other symptoms they list and since I have had this tenderness for a couple of days, I kind of doubt that it is temporal arteritis, since my eyesight is still as good as last week. I have read where you could lose it in 48 hours if you really had this.
As I write this, it seems to be virtually gone so I will just have to follow it and if it returns or stays I will go to see my doc. Thanks again.
Anyone ever hear of tenderness of the temple being anything other than GC arteritis? You would think being on V would dramatically reduce risk of blood vessel inflammation, but my moron doctor has never ordered a hsCRP.
Not a PiGgy fan, but most small bios were down yesterday. He has to know that if nothing changes, he is out at the next AGM.
And who knows, maybe sooner. Didn't one of those MKT or Iljin threaten to call for a special meeting?
I believe Sleven gave you the best answer. I will just expand a little. I can remember even when Amarin's stock price after R-I was flying high, many here (probably including myself) were bitching that the analysts and market was not valuing the European opportunity for V correctly. We now, after these past few years, know that the market and analysts were more accurate than many of us figuring how difficult it is to break through in that market (at least for a tiny one drug company like Amarin).
I say all that to highlight that our stock price currently reflects very little of the EU opportunity and the static but ever degrading US market. The market is forward looking and values growth that it can see going forward. So ultimately to get to your question, even any excitement over any potential benefit from any positive AD results (from BRAVE-EPA) is not showing up because
a) it would be years before V could get approval and,
b) the idea is that any off-label scripts written for V (for AD) would be chewed up by the Generics no differently than the scripts written for CVD. Yes, Amarin seems to be holding US scripts somewhat steady but at the cost that they have dropped their margins to the point where on hundreds of millions of dollars of sales, they are not making any or very little profit.
But ultimately, for us investors, this is where the potential windfall lies. Like Sleven pointed out, the expectations are low currently. If Amarin can change some dynamics and start to show profits, the market will start chasing us and the stock price higher as they would be missing out. Buffett I believe said that the market is a mechanism that transfer wealth from the impatient to the patient. Let's hope that works here soon because many of us are on the verge of losing patience.
To me that “logic” seems strange. For the population that they are suggesting reimbursement (cvd on max statins and trigs between 135 and 500), how come they are not questioning results and placebo? Same placebo.
Agree with your numbers JRoon, with one caveat. We also have to take into consideration margins and net profit. With all the generics in the U.S. Amarin would have to take smaller margins and only a portion of sales here. But generally yes, if we could get AD as an indication that would change the dynamic in a big way.
Of course, even assuming stellar BRAVE-EPA results, approval imo won't be imminent but rather years away and something an acquiring BP would have. But I would factor that into BO negotiations.
No question. Not to make fun of JT, but the data was robust.
Does the ADA have a French equivalent and if so why didn't such organization petition HAS:
https://diabetes.org/newsroom/press-releases/2019/ada-issues-critical-updates-to-2019-standards-of-care
Yep. One would think (or at least hope) that even if they prioritize cost savings over patient health care that Vazkepa is a relatively cheap drug -- for the benefit it provides. That article or study posted by Kiwi included drugs that were far more expensive than V.
I am just wondering why HAS recommended excluding Vazkepa from diabetics as I thought R-I had great results within that segment.
Thanks Sleven for posting. The recommendation from HAS then goes (went) to the Health Ministry which then decided the reimbursement.
I am wondering if HAS’s refusal to include diabetics in the recommendation is a sticking point. I was not aware of that exclusion to V’s potential use in France.
Well, b) was no Oracle of Delphi revelation. As far as a) a classic example was KM thinking more of himself and bailing rather than working with the new team for the benefit of shareholders. Who would want that money grubbing group who were derelict in their fiduciary duties to shareholders.
Are you saying he was right about:
a) that we would be better off with the old guard
or
b) that the jump in stock price would drift back down?
If it was b) there were many of us that voiced the same idea that the pop in price on the news would be sold off as of course we all know Amarin's situation has not or will not change in a matter of weeks or months.
It says here that the last update was October 10, 2022, so later than your 2019 date.
It also says the study completion date (assuming it is not delayed further) is Sept. 29, 2023. But remember that they will then have to slice and dice the trial data and it may be 3, 4, or more months before we should expect even simply top line data.
https://clinicaltrials.gov/ct2/show/NCT02719327
I used to not have a very confident outlook concerning V wrt delaying, treating, or preventing AD. One of the main reasons was that AD is and is expected to explode in Japan. I was very confident in R-I results because of the low incidence of CVD in Japan (high consumption of EPA in the diet), and so thinking along the same lines, I was not confident that EPA would be very helpful in AD.
BUT I have changed my outlook. Here is an article outlining the rapid increase in AD coming the next years in Japan:
https://www.clinicaltrialsarena.com/comment/japan-will-fastest-growing-prevalent-cases-alzheimers/
BUT, the caveat is, that those larger numbers will be primarily because of the huge amount of aging Japanese, and aging is one of the big factors in AD. The other thing, that is not mention in the link above, but I have read about, is that the diet among the Japanese is changing. It could well be that although the geriatric population used to eat a diet high in EPA, that as they have aged and some of them in retirement homes, that they no longer eat as they used to. So all in all, I am hopeful that V can show some benefit to those susceptible to dementia and AD.
Sleven, JRoon, a good example of the new FDA standards and thinking was their approval of lecanemab earlier this year:
https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
Lecanemab trial was considerably larger than BRAVE-EPA, was done on subjects with mild AD vs cognitively healthy subjects in BRAVE-EPA. IMHO, positive results in BRAVE-EPA would be greeted with calls for a larger study but would still boost stock price and would definitely spike interest with the BP community.
Thanks for reposting Sleven. I believe Cindy Carlsson and possibly Carol van Hulle are involved in the BRAVE-EPA trial.