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Amarin Corporation plc Message Board

jesse.livermore 21 posts  |  Last Activity: Mar 29, 2015 8:02 AM Member since: Aug 21, 2009
  • 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

  • jesse.livermore jesse.livermore Feb 25, 2015 11:57 AM Flag

    To further clarify the JUPITER comparison to REDUCE-IT,

    JUPITER would have generated roughly 525 or less events at a 1.5% annual risk rate for the median 2 year follow up. This lead to 50% or more reductions in some events (significant), but only 20% in all cause mortality (not stat significant)

    We know from the AdComm disclosures that there were already 200 events in REDUCE-IT in the fall of 2013. At a 5% annual risk rate (approximate estimation of R-I rate) this translates to a one year follow up in 4000 patients. Since that time we have added the events of 7000 patients for 1.3 years. This amounts to 453 additional events if we accord no benefit to Vascepa. If V reduces risk by 40% then there would still be an additional 363 events which would total 563 events, which are still more than the JUPITER trial...Remember the keys are simply the number of events and risk ., doesn't matter if you got there with huge patient numbers and small risk (JUPITER), or small patients at very high risk (REDUCE-IT)

    So right now we actually have more data than JUPITER did when they stopped the trial. The Safety committee stopped the because the placebo group was operating at 50% higher risk, even though their risk was actually very low (1.5% annual)...In R-I it s is more crucial to stop the trial if their is a higher risk in the placebo, because the overall mrisks are much higher,

  • jesse.livermore jesse.livermore Feb 23, 2015 6:15 PM Flag

    OK..Let's settle this.

    In R-T there were about 200 events in the data presented pre AdCom. The difference in expected vs actual was not enough at that time to overcome randomness.

    Re: JUPITER..this acronym stands for Justification for the Use of statins In Prevention: an interval trial Evaluating Rosuvastatin.

    The idea behind the study was the observation that about 50% of heart victims have normal lipids. The study was to test whether inflammation was a contributing factor to CVD events and whether hsCRP was a valid marker for risk. To study this AZN selected about 17,500 men and women who had no history of heart disease, had LDL-Cs under 130 mg/dl, considered normal at that time,, but had elevated hsCRPs.

    JUPITER was a multi site trial with cases added each year. Because of selection criteria, the RISK IN JUPITER WAS VERY LOW. The CVD event risk was only 1.5% per year...ie less than 1/3 the placebo risk in R-T. The median follow up, until the the trial was halted, by the Safety committee was only 2 years. This is all event driven...If you do not understand that you should refrain from posting. Basically a scenario where R-T was halted in the next 10 months for efficacy (placebo group safety.) would be perfectly consistent with what happened in JUPITER. In JUPITER the interval was just set a earlier when taking in account the number of events.

    I am not interested in whether there was a study stopped before interval and am certainly not wasting my time researching it.. If there is a placebo safety issue they will halt it.

    ": ) JL

    Sentiment: Strong Buy

  • jesse.livermore jesse.livermore Feb 23, 2015 1:12 PM Flag

    "If anybody has science to show predictions, we are all waiting. "

    OK...While it is true greater Vascepa efficacy in the R-I trial will lower the event rate and prolong the time it takes time it gets till we see 967 events, this does not mean it will prolong the time the trial will be halted...

    Say What??....Actually there are only two entities that can stop the trial at any time...That is the sponsor Amarin, or the Safety and Ethics Committee. The DMC and the FDA can make recommendations which the company might or might not agree with. The Ethics committee has the power to halt the trial at any time there is a concern that human subjects are being exposed to unnecessary risk. The way the trial is set up is the placebo event rate is estimated by actuaries at 5.2% per patient year. This is considered to be a very accurate number. Imagine a trial with 10000 enrollees 5000 in the placebo, 5000 in the treatment arm. annual event rate is 5%, If Vascepa has no effect, the trial will be as 10000 placebo, and the expected number of events will be 500 events. If V is dangerous then the number would be higher than 500. For this reason all studies are monitored for total events at quarterly intervals.

    Now what happens if V is very effective at cutting CVD events. Well the total events number drops. Since only half the trial is on V, a decrease in number of events,say 10% less than predicted for 10000 placebo, suggests the rate lowering effect is twice the measured percent. The only other interpretation is the initial rate estimation in the placebo group was too high. In either case the study would be halted if the events measured are significantly lower than predicted. At 15% under placebo, the Ethics Committee would insist on halting the trial to protect the placebo group from a 30% higher risk of CVD. Even if this reduction proves due to the risk estimation the trial would be halted from insufficient power (study would take too long)...

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    New Research Questions Statin Use

    by ganj1948 Feb 22, 2015 3:50 PM
    jesse.livermore jesse.livermore Feb 22, 2015 11:05 PM Flag

    jetman...Nice try...a few small corrections in your post...First off most of the studies which showed statins reduced CVD events were run prior to the 2006-2007 Clinical Trials Reform Act. These were sponsored and run by the drug companies that manufactured the drugs...and well, as you might guess, they tended to support the company's products. There is actually only one really compelling statin trial, JUPITER (AZN) which showed statins reducing risk. UIn JUPITER the enrollees had low LDL-Cs in the normal range.

    A large (500,000) population study reported that statin users were from 10 to 22 percent more likely to develop diabetes than non statin users.

    2% of V takers developed arthralgias, not "severe myalgias". The drug insert does not say V might cause acute pancreatitis. It says"the effects of V on the risk of pancreatitis with severe hypertriglyceridemia are not known. The literature (based on population studies) supports the notion that EPA lowers the risk for prostate Ca.

    Statins may be of some benefit, but they come a good deal of baggage. Effects on cognitive processes and the mitochondria are to me the most worrisome.

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    Private Placement Oct 2009

    by dendreonpro Feb 21, 2015 7:04 AM
    jesse.livermore jesse.livermore Feb 21, 2015 7:39 AM Flag

    If I understand this correctly there were about 37 mil warrants issued from the 2009 placement. This actually kicked off AMRN's foray into the CVD arena. Certainly most of these warrants were exercised long ago when the PPS was an order of magnitude higher. Trying to understand what their effect on the PPS would be at this time other than the fact they expire at the end of next week...Hard to believe anybody was/is dumb enough to still be holding them. At any PPS less than $2.00 (50 cents for the warrant and $1.50 to exercise ) you are losing money. If you want the shares you can buy them cheaper, and no dilution.

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    Until "news" hits the wires

    by bobobaginz Feb 20, 2015 8:12 AM
    jesse.livermore jesse.livermore Feb 20, 2015 9:13 AM Flag

    Bobo...How did your baginz taste?....So far from a trader's view, the runup looks solid, good price action, good volume, with the stock closing on the high of the day...Pretty much everything a trader, not in the least bit interested in the fundamentals, could ask for. Consider the fact this issue is now on every mo-mo's screen flashing a lovely shade of green.

    Doubt anyone on this board knows what is behind this, but it is unlikely to be the warrants, or the up grade. These are much too trivial. IMO you have to look at the Stonepine purchases which are a much more endorsement of AMRN than some analyst's upgrade.

    Sentiment: Strong Buy

  • Reply to

    IMO this "rally" is suspect

    by bobobaginz Feb 19, 2015 2:53 PM
    jesse.livermore jesse.livermore Feb 19, 2015 3:44 PM Flag

    exPlain.....not so many warrants (around 8.5 mil) and more than 12mil shares, a week before X-date.

    So far this is looking pretty legit from a trader standpoint , 5X ADV on day one with good follow up in price and volume day two (needs to hold to the close). So far, as strong as horse radish.

    ": ) JL

  • Reply to

    Stonepine Capital discloses 9m share position

    by akanz2 Nov 19, 2014 3:08 PM
    jesse.livermore jesse.livermore Feb 16, 2015 10:53 PM Flag

    Cheerleader...

    According to the last DA filed by Stonepine in Oct 2014, they have just over $30 mil in the fund and 61 investors. Buy in minimum is $250k. Not sure if it is qualified investors only. They have roughly 33% of their capital in AMRN, the most concentrated position I can remember for a public fund. There are three principals, one is a tax accountant and the other are "Wall Street" types. Lynch is former Goldman-Sachs by way of Harvard B School.

    The SEC is going to be more interested in this investment than a hawk sailing over a prairie dog town if they jackpot , and there will be more plaintiff subpoenas than maggots on a dead horse if R-I fails. They can not be trading on insider info. They have figured out there is already enough data from the double blinded R-I, if you make the highly likely assumption the placebo rate is 5.2%, then if you extrapolate the early numbers to get the total events, it is simple arithmetic to determine the active arm event rate...

    A smart bet, by smart guys...

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    Why FDA haven't yet ruled on sNDA? JL?

    by rafunrafun Feb 9, 2015 11:56 PM
    jesse.livermore jesse.livermore Feb 10, 2015 7:22 AM Flag

    Re: the delayed sNDA ruling. Have no insider knowledge. The FDA does not negotiate with drug companies. The FDA specifies requirements and notifies the companies if they have met the requirements or not. Most likely this is a case of the FDA not giving the company a passing grade or a failing grade, but marking them as incomplete. The incompleteness could be based on the current scientific evidence the FDA is viewing regarding the efficacy of statin add ons. The FDA could change its mind at any time if it determines there is new substantial evidence. Meaningful reductions, (over 15% ) of CVD risk in the Vascepa arm of REDUCE-IT trial would end the suspense.

    ": ) JL

    Sentiment: Buy

  • jesse.livermore jesse.livermore Feb 9, 2015 9:05 AM Flag

    (cont) The possibility the event rate estimation is way off, is not very likely. These numbers are determined by actuaries who set the odds for insurance companies, and they are very good at what they do (and highly paid) The second reason the events may be too low, and the most likely reason is the drug (in this case V) is highly effective. The DMC might for example allow the trial to continue if there was a ten percent reduction in events under the 364 annual events predicted in 7000 placebo patients. Since the study is equally divided 3500 placebo, and 3500 Vascepa treated, a drop of ten percent would mean the drug was reducing the risk by 20%...At higher than 10% "missing events" this would suggest rates possibly in the 30 or higher, and this would bring "ethics" in to protect the placebo group from being put at unnecessary risk. Looking at sub sets in JELIS...secondary intervention mixed dyslipidemia suggests a 50% reduction is a good bet for the R-I ...

    ": )JL

  • jesse.livermore jesse.livermore Feb 9, 2015 8:50 AM Flag

    Investspecial...

    Obviously you are not a math major.

    Looking at the data and rounding 9319 down to 9300 inn this group we have 324 "events" in a four and a half year period means there were 72 "events" per year in the control (placebo) group. This means the annual risk of an event in JELLIS for them, was about 00.8%..The point being the Japanese women who were the main component of JELIS were at very low risk of CVD events.

    The R-I population is a tune from a different opera. The actuarial estimated annual risk in R-I, considering the fact the study selected for secondary intervention patient with poor diets, is 5.2%..
    This means the average enrollee in R-T is at six times the risk of the average JELLIS enrollee.
    The number of likely events in these studies is the product of the number of patients times the annual risk rate times the length of the study in years. Plugging the numbers in here at 7000 patients in R- I at 5.2% would generate 364 events for every year the study runs, if the drug is ineffective.

    But this is not even the interesting part. The DMC which monitors these studies is under the watchful eye of the safety and ethics committee which trumps all when it comes to these human studies. The rule being you can not deliberately put human subjects at risk. So even if the study remains "blinded", it is never really blind. Adverse events must be reported. The DMC also receives periodic event rates without a breakdown toward the separate arms, again because higher or lower expected event rates may be associated with unnecessary risk. It is easy to see how higher rates than anticipated rates could indict the V, but, lower than anticipated events are also important. Lower than expected rates result from one or two reasons. The first is the the estimated risk rate is too high and the real rate is lower than calculated. This can lead to stopping the trials simply because they a too under powered and would take too long to show meaningful results.

AMRN
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