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Amarin Corporation plc Message Board

jesse.livermore 10 posts  |  Last Activity: May 1, 2015 8:01 AM Member since: Aug 21, 2009
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  • Reply to

    BioBillionaire (Jason) from i-hub

    by rafunrafun Apr 30, 2015 5:16 PM
    jesse.livermore jesse.livermore May 1, 2015 8:01 AM Flag

    Jason, (BioBillionaire) never claimed he was a billionaire. He was a little over the top and given to outlandish statements like, I'm going to stick my boots up the FDA's #$%$. Or the they (the FDA principals) are going to jail. Stuff like that. Most of his predictions turned out to be wrong, but that's true of a lot of us.

    Jason was a good guy generally polite to most posters. He did comb through the government filings, particularly about our filing of a citizens petition to redress wrongs done by the FDA. Of course the FDA ended up throwing all our efforts in a big trash bucket, after a couple of lies and some BS arguments.

    He will be missed, and I hope they reinstate him soon. Interestly he is a paying member of Ihub, and usually they are immune to this kind of treatment. Don't know what he said, it was scrubbed very soon after. Maybe someone knows what the post said.

    ": ) JL

    Sentiment: Strong Buy

  • jesse.livermore jesse.livermore Mar 29, 2015 8:02 AM Flag

    mario....Sorry to disagree, but when the judges decides, is not going to be contingent on the internal structure of the FDA..If you read the transcripts, at the end of the session the judge thanked both sides and offered them an opportunity to submit other comments on points made during the trial. This was a day or two thing. The judge stated he had much to think about, But promised he would do his best to get his decision out as soon as possible, because he understood there was some urgency .

    Would expect we would see something out within a months time..Most likely a favorable outcome for Amarin.

    ": ) JL

    Sentiment: Strong Buy

  • jesse.livermore by jesse.livermore Mar 6, 2015 7:28 AM Flag

    Dilutions are like watching your mother-in-law drive your Ferrari off the cliff.

    A little surprised the company floated this issue at this time, but may not be the worst thing. First off if AMRN is to grow into a really big company, and I have always thought they will partner, but never sell (unless the offer is really "stupid"), having a float of 150mil shares is not going to provide the liquidity needed for funds to trade the stock, so the dilution from a long term standpoint (about 32 mil shares) is trivial and perhaps even beneficial.

    From a financial standpoint, at a current burn rate of 13-14 mil/quarter this translates a little less than a year's
    worth of operating capital. But it may signal Amarin is planning to up grade in some area, marketing? research?, or a law suit?

    Be very interesting to see how the market reacts to this...50/50 up or down..

    ": ) JL

    Sentiment: Strong Buy

  • jesse.livermore jesse.livermore Mar 3, 2015 10:13 PM Flag

    These predictions may not be totally accurate. The important thing is they do not over estimate the effect of the. The drug may have greater benefit, but it will not have less efficacy.

    ": ) JL

  • jesse.livermore jesse.livermore Mar 3, 2015 10:05 PM Flag

    The answer is "divergence" In some clinical trials, in the early months of the trial the placebo and the treatment charts of events tend to stay fairly close together. Think of it as the drug taking a period of time to produce its effects. Then gradually the the chart lines begin to diverge with less events occurring in the treatment arm. This is what happened in JELIS. If you know the total number of events in the trial and determine the rate (percent) of events for the first year this gives you a very good estimate of what the placebo arm risk rate is. More importantly, it gives you the lower limit of what the placebo risk is because it includes the treatment arm which will be lower than the placebo arm. This means using this first year placebo risk rate you are not going to under estimate the risk in the placebo arm which would lead to false hope for the drug. This also counter acts the possibility risk rate in the placebo group is increasing over time, because untreated patients get sicker over time.

    So what this means is roughly around a year and a half you can use your early risk determination and apply it with certainty to the measured total event number and predict Vascepa's risk reduction on the basis of percent less total events than would be predicted by the placebo risk rate...eg if the measured events are 10% lower than the placebo prediction, then the efficacy is 20%, if 20 % lower, it's 40% etc.

    ": ) JL

    Sentiment: Strong Buy

  • REDUCE-IT is a double blinded trial. The only data available is the number of total events, placebo arm and active arm delivered at quarterly intervals to the company. This information, along with ADRs (adverse drug reactions) is provided to the company to identify possible safety or trial design issues.

    Recently we have seen some very positive events where people outside the company a voting with their wallets that REDUCE-IT is gonna be a winner. That would include Stonepine HC putting 33% of its capital into AMRN, The China deal and the 50% plus rise in the PPS. How can they be so sure?.

    Expectations of events are calculated by actuaries prior to the trial so at least in the placebo arm the events over should be predictable within a narrow range. So in a trial of equal placebo and treated arms if the placebo group risk is 5%, the risk for the entire trial is 5% if the drug is completely neutral. If the total events are greater than 5% then the drug could be dangerous, if the events are less then the drug is working. The problem is you need to be absolutely certain the risk estimate is accurate. If not lower or higher risk could be due to a inaccurate risk estimate. So how can you tell if your risk estimate is accurate without unblinding the study?

    Cont.....": ) JL

  • In CC they have gone just about as far as legally permissible to tell the Street that REDUCE-IT will blow the doors down..

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    The China Syndrome (The truth be told)

    by zumantui Feb 27, 2015 7:39 PM
    jesse.livermore jesse.livermore Mar 2, 2015 9:45 PM Flag

    akanz2...Criticism accepted..

    Statin effects on cognition is a murky pool. Your point about the 2013 study, all 5,287 patients , all three years, needs to understand somebody paid for that study and face it, it was most likely a statin company. Cognitive decline is so hard to measure, because the starting off varies so much from person to person. Kasparoff could probably beat both of us in our best chess game even if his cognition was off by 80%.

    The fact is cholesterol is found in high concentration in the myelin sheaths that protect nerve transmissions and is a vital structural component of cell membranes. A small study run by a dedicated scientist might hold more truth than a large study influenced by financial considerations. This is not "biostatistics", this reality.

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    The China Syndrome (The truth be told)

    by zumantui Feb 27, 2015 7:39 PM
    jesse.livermore jesse.livermore Mar 2, 2015 5:35 AM Flag

    Patients completed a survey assessing statin-associated, cognitive-specific The statinista cardiologists see no evil in statins...but reports such as this one in medscape tell a different story.

    "adverse drug reaction (ADR) characteristics, relation of the ADR to specific statin and dose (or potency), and time course of symptom onset and recovery. Visual analog scales were used to assess the effect of the cognitive ADRs on seven quality-of-life domains. Demographic and clinical data were also collected. To target cognitive ADRs with a probable or definite causal relationship to statins, the Naranjo adverse drug reaction probability scale was used: 128 patients (75%) experienced cognitive ADRs determined to be probably or definitely related to statin therapy. Of 143 patients (84%) who reported stopping statin therapy, 128 (90%) reported improvement in cognitive problems, sometimes within days of statin discontinuation (median time to first-noted recovery 2.5 wks). Of interest, in some patients, a diagnosis of dementia or Alzheimer's disease reportedly was reversed. Nineteen patients whose symptoms improved or resolved after they discontinued statin therapy and who underwent rechallenge with a statin exhibited cognitive problems again (multiple times in some). Within this vulnerable group, a powerful relationship was observed between potency of the statin and fraction of trials with that agent resulting in cognitive ADRs (p

    Sentiment: Strong Buy

  • Reply to

    The China Syndrome (The truth be told)

    by zumantui Feb 27, 2015 7:39 PM
    jesse.livermore jesse.livermore Mar 2, 2015 5:19 AM Flag

    Zumantui...sounds like a cross between Chinese and Italian pasta, Can I call you "Tui".?
    Tui is Tu with an edge. Zumantu is Rob Low and tui is "Just dropped off the Ihub board because I ODed on BB's rants" and PS I don't have Direct TV.

    akanz2 might be the most proximal example of what happens to your brain when you take statins in large doses over a period of time. As the evidence begins to pile up statins might be compared to aspirin "with problems" . The problems include cognitive issues. Since it is unusual for patients to have their cognition monitored year by year statins' nasty little secret has largely been kept in the closet or attributed to "getting older". Also the financial landscape favors the foisting off of statins over the mental health of the middle aged. Somewhere in the transfer of billions someone should have ask if blocking the production of cholesterol, a molecule tied to so many basic physiological functions, was really such a good idea.

    Yes R-I is certainly about adding EPA to statins. The next step should be getting rid of the statins.

    ": ) JL

    Sentiment: Strong Buy

AMRN
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