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Amarin Corporation plc Message Board

frenzychess 84 posts  |  Last Activity: 51 minutes ago Member since: Sep 3, 2003
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  • From the Stumbling Bear account, Judge Moss and Engelmayer, it seems to me, had similar reactions to the FDA's arguments. Those Judges just didn't buy anything the FDA was selling. Seems very promising.

    Sentiment: Strong Buy

  • frenzychess by frenzychess 21 hours ago Flag

    This is the first time in history a drug manufacturer has sued in court citing first amendment protection where thethat drug company hadn't first violated the FDA's off label promotional ban. If Amarin wins they get a portion of ANCHOR, but far less then what full ANCHOR would have accomplished. They're missing FDA on label approval for 200-500 mg/dl trigstrigs patients and insurer exclusivity for that class. However, this case will be covered extensively in the medical community and a positive result will gave a magnified impact on prescribing patterns. By the way...tomorrow is a huge day.

    Sentiment: Strong Buy

  • frenzychess by frenzychess Jul 4, 2015 10:38 PM Flag

    This trial gives Amarin the right to reveal truthful ANCHOR trial results to doctors. Those results, along with winning a trial against the FDA should boost sales by several times. Losing the case will cause the price to fall maybe 5%, but since REDUCE-IT trial results are so impactful and close to the interim, the price will come back quickly. It's a good time to be in AMRN.

    Sentiment: Strong Buy

  • Reply to

    Things People Might Not Know

    by frenzychess Jul 3, 2015 10:36 PM
    frenzychess frenzychess Jul 3, 2015 11:21 PM Flag

    Oh yes, I would like to see the price rise, but it doesn't go up based on what I say. 7/7/15 is likely to be a good day based on Amarin's respsonse letter. That rise though will be based on what Judge Engelmayer says. My points above are especially relevant since Engelmayer's decisions on free speech would likely favor Amarin's position. Anyhow, I'm just frenzychess, not the guy who has helped push this issue along to judicial review through courageous pursuit. I'm not that, I'm just a piece of stinking flaming cheese.

  • Reply to

    Things People Might Not Know

    by frenzychess Jul 3, 2015 10:36 PM
    frenzychess frenzychess Jul 3, 2015 10:59 PM Flag

    I think it's interesting and helpful to know the environment surrounding this case. By the way, I'm just frenzychess but thanks for the compliment.

  • Currently the house and senate are reviewing the FDA's overreach on SPA's. Floyd Abrams, Amarin's attorney, just won a labeling case for large tobacco.

  • Reply to

    Do No Harm

    by frenzychess Jul 1, 2015 11:59 PM
    frenzychess frenzychess Jul 2, 2015 12:26 AM Flag

    Good luck to you too. I would have thought the Amarin response with a great lawyer in full lather might have sparked a bit more notice from the market. I'm certain it will catch more notice as we close in the on the 7th. I don't see anything in Judge Engelmayer's rulings that tells me he's easily distracted, say, by an HHS study finding excessive use of Vascepa by conniving seniors forcing their doctors into nasty prescribing habits. I have no way of proving this of course, but I think this rather thoughtful Judge is thoroughly revolted by the FDA's actions in regards to Vascepa at this very moment. Judge Moss was rather surprised by the FDA's thought processes in the NCE decision. By comparison, NCE vs. ANCHOR is not a contest. NCE was a very difficult scientific maze of questions, whereas approving ANCHOR was straightforward. The FDA had to do perform regulatory gymnastics to make Amarin's SPA go away. The FDA cannot produce a decision like the one they came to with Vascepa through any other decision, they don't exist. The FDA would be 100% inclined to approve any other drug with Vascepa's characteristics under the conditions imposed.

  • frenzychess by frenzychess Jul 1, 2015 11:59 PM Flag

    Not harming people is the most precious thing that Vascepa does, it doesn't kill you or disable you. PCSK9 doesn't have any history whatsoever and the FDA is going to approve it fairly quickly. In a decade or so, when 8% of those patients develop Alzheimer's, put a warning on the label I guess, (who knows what it'll do in a decade, the FDA certainly doesn't). Hundreds of FDA approved drugs kill and/or disable people and it usually happens years after approval as side effects emerge. FDA approved drugs kill over 100,000 people per year in the US. Few FDA approved drugs have a safety profile as benign as Vascepa's, if any. Epadel, Vascepa's sister drug, has been around for over a decade and the side effects are minimal, tiny, with a population that eats fish like popcorn, so they've had EPA overload for years. It is against this backdrop, and a very promising ANCHOR trial and another study showing efficacy in actually reducing heart disease, JELIS, that the FDA decided to thwart Vascepa. There aren't enough expletives available in the English language for what they've done, because all the other drugs used off-label in the high triglyceride market have more side effects. Since the FDA gave these drugs labeling based on finishing long term studies, they have been grandfathered in, with insurers comfortable giving them priority over newer drugs like Vascepa. So patients suffer and miss out on likely their best chance to avoid a future heart attack because Vascepa is the wrong tier.

  • Reply to

    Game Set Match

    by frenzychess Jul 1, 2015 10:24 AM
    frenzychess frenzychess Jul 1, 2015 10:01 PM Flag

    Hi Janet

  • frenzychess by frenzychess Jul 1, 2015 3:25 PM Flag

    Normally, when the FDA is being sued, there has been a thread of logic in all the steps that led to the lawsuit. That thread of logic is what's missing here. So this case will proceed along unfamiliar paths for both the FDA and court watchers. Engelmayer is going to want to know why the FDA did pretty much everything the way they did, and their answers cannot satisfy those questions. This will be quite embarrassing for them. Wall Street hates uncertainty and that should go away the moment EngelmayerEngelmayer addresses this case. Unlike dealing only with the FDA, there is a light at the end of this tunnel and it's called justice.

  • Reply to

    Game Set Match

    by frenzychess Jul 1, 2015 10:24 AM
    frenzychess frenzychess Jul 1, 2015 12:48 PM Flag

    On ihub post 52782, also on PACER. I suppose the market needs to hear Judge Engelmayer weigh in on this. He's not an ideologue so the FDA is in huge trouble. Their arguments show a pattern of manipulation to deny Vascepa any chance of penetrating the high trig market, in fact, with the latest HHS study, they're bullying doctors away from prescribing Vascepa. This Judge is gonna flip out on them. On 7/7 his words will tell the market all it needs to know.

  • frenzychess by frenzychess Jul 1, 2015 10:24 AM Flag

    Not sure how much clearer it can be. FDA said they were worried Amarin might not finish R-It if they won this case. Amarin says they'll finish R-It even if they win. They can be sued out of existence if they don't finish R-It now, so Amarin can win and the FDA needn't worry. Its over before it began.

  • Reply to

    AMRN Responds to FDA

    by cyliu1222 Jun 30, 2015 6:06 PM
    frenzychess frenzychess Jun 30, 2015 7:03 PM Flag

    No hint of the boy scout Amarin remains in that response. Nice Amarin doesn't exist anymore

  • Reply to

    So, You Ignore What?

    by frenzychess Jun 29, 2015 10:23 PM
    frenzychess frenzychess Jun 29, 2015 11:10 PM Flag

    Oh, agree 100%, and I believe tomorrow is the rainmaker. Geez, does anyone realize the tangled web this FDA has woven to blunt Amarin at every turn. For NCE, I thought the issue was pretty complex, but Moss didn't take that long to see through the fallacies in the FDA's arguments. What the Swalchies of the world are forgetting here, (sorry Swalchie, look away), is that while the argument against Vascepa due to TG reduction and other studies makes some sense; in totality the decision flies against dozens of other decisions they've made. In other words, the FDA's process for coming to the conclusion to deny ANCHOR doesn't make any sense when they've approved other drugs like Triplix and Niaspan and Lovaza, making them billion dollar drugs, with NO JELIS to back them up. It's this inconstancy of action and focused rebuke to every reasonable request Amarin has made that's so damaging. For Pete's sake, Floyd Abrams is the lawyer and the FDA is delusional.

    Sentiment: Strong Buy

  • frenzychess by frenzychess Jun 29, 2015 10:23 PM Flag

    Judge Engelmayer's head is going to explode, I can imagine him asking Janet Woodcock the following question: "So, because the overall JELIS population had a 150 mg/dl reading for triglycerides, you're going to ignore a 53% reduction is CVE in the most relevant sub-group because overall triglyceride reduction was only 5% for everyone?? Are you insane?"

    Sentiment: Strong Buy

  • Reply to

    Pentagon Papers

    by frenzychess Jun 29, 2015 7:56 PM
    frenzychess frenzychess Jun 29, 2015 8:36 PM Flag

    Well, there was some carnage today I guess. Grease 2 was terrible.

  • frenzychess by frenzychess Jun 29, 2015 7:56 PM Flag

    Amusing day, Amarin down 4%. Doesn't really make a whole lot of sense though. The gentleman defending Amarin once beat an angry Executive Branch by defending the NY Times after their release of the Pentagon Papers. Thats what's starting tomorrowtomorrow, Floyd Abrams vs. Janet. The markets realization of little Amarin's hired gun starts. The FDA shoulda compromised.

    Sentiment: Strong Buy

  • frenzychess by frenzychess Jun 29, 2015 9:16 AM Flag

    Floyd Abrams only picks big cases that he can win. At this point in his career there is little need to do anything else. So consider this is a landmark case that Amarin will probably win. Arguments with Abrams guiding hand take form June 30th. This is a good thing.

  • Reply to

    What Kind of Action Will We See This Week?

    by richardson4726 Jun 29, 2015 8:01 AM
    frenzychess frenzychess Jun 29, 2015 8:27 AM Flag

    Should be one of the most interesting weeks ever.. The market is taking the FDA's position seriously, but that all changes with Amarin's letter. Instead of this being just a first amendment case, the actual science of Vasepa will actually be layed out against the FDA's version. Shorts should hide.

  • Reply to

    Coronia + Abrams = Memories

    by frenzychess Jun 27, 2015 11:34 PM
    frenzychess frenzychess Jun 28, 2015 9:30 PM Flag

    Hey, I'm not Williams4076, I'm not anywhere near as informed or as relevant. I am glad though, Williams4076 exists. And please stop debunking JELIS. The trial was an amazing success especially for the sub population with higher triglycerides and lower HDL. REDUCE-It is introducing 4 grams, not 1.8 daily to a population similar to the sub-population in JELIS. The participants basically eat a western diet and have little EPA intake otherwise, far different than the Japanese who carry far higher levels of omega-3's. Chances for success are extremely high. One thing that is most telling in JELIS is the exponential gains in the chart. The improvements expand faster and faster over time.

AMRN
2.46-0.04(-1.60%)Jul 7 4:00 PMEDT