Recent

% | $
Quotes you view appear here for quick access.

Allergan Inc. Message Board

jesse.livermore 28 posts  |  Last Activity: Jul 3, 2015 9:09 AM Member since: Aug 21, 2009
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    Stock price movement = total fiction

    by to_the_pain Jun 23, 2015 10:35 PM
    jesse.livermore jesse.livermore Jul 3, 2015 9:09 AM Flag

    PPS = total fiction...eh?.... PPS was $.83 on Nov 10 2014. Thats up 300% in six months buckaroos. That kind of profit would have Warren Buffett dancing the Funky Chicken. Traders are "picking up pennies in front of a steam roller.

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    Short @$2.47 30,000 shares

    by optionjoe5 Jun 30, 2015 7:13 PM
    jesse.livermore jesse.livermore Jun 30, 2015 7:29 PM Flag

    What you are doing is picking up pennies in front of a road grader..

    Its you that's gonna need the luck

  • Reply to

    Excellent

    by frenzychess Jun 8, 2015 7:47 PM
    jesse.livermore jesse.livermore Jun 8, 2015 8:07 PM Flag

    Well stated....agree.

    Actually by running on so long and saying so little the FDA has managed to bring all their zany interpretations and perverted logic from the Oct 2013 AdCom into the trial. Something Amarin's stellar lawyers would have probably not been able to accomplish. FDA is a rare combination of arrogance and stupidity. They got slobber knocked by Judge Moss....

    Hello Chapter 2

    ": ) JL

    Sentiment: Strong Buy

  • Reply to

    Article about MAT9001 and Vascepa

    by onlyfactsplease Jun 3, 2015 6:11 PM
    jesse.livermore jesse.livermore Jun 5, 2015 9:52 AM Flag

    facts,...

    Please understand I do think DPA raises some serious questions about the future of w-3s as treatment for CVD and other chronic inflammatory diseases. Right now I do not know the answers to some of the questions, and am not sure the answers are known. For instance is DPA in essence (for all practical purposes) a metabolite of EPA ? Apparently DPA and EPA are inter convertible in humans. One article stated that is some interactions EPA is converted into DPA and it is DPA which is the active moiety. This raises the question of possible EPA benefits that DPA might not have . This might seem unfair, but at present the literature on EPA is vast and the literature on DPA is not vast.

    Does insuring adequate levels of EPA effectively solve the DPA deficiency problem?

    I am fascinated by your comment that MTNB can make DPA from other w-3s. Is that really true?
    Again the economies of supply are important. I guess they must be looking for the right
    algae.

    R-IT might obviate MTNB having to run an outcome trial, but that 's a big if...

    ": ) JL

  • Reply to

    Article about MAT9001 and Vascepa

    by onlyfactsplease Jun 3, 2015 6:11 PM
    jesse.livermore jesse.livermore Jun 3, 2015 9:34 PM Flag

    Dear facts...

    Suggest you stick to them...The MAT9001 story was not the lead story on the AMRN IHUB message board, That would be the FDA's actions on the First Amendment case.

    I would not get too excited about the article you cite. A standard plant to catch the suckers...Facts are...We don't even know the composition of MAT9001 so how can we come to any firm conclusion. We know it contains DPA and presumably its magic emanates from that particular N22 w-3. Even though EPA and DPA are inter convertible in humans, lets assume DPA...lowers PCSK9, lowers trigs and other non HDL_C lipid components, more than EPA, Lowers inflammation and oxidation more than EPA...the works...All things that remain unproven. This still does not necessarily make DPA a contender with EPA...We are not talking rare diseases here. In marine oils DPA averages about one tenth the amount of EPA...And don't start talking about killing the few seals that remain on the planet. To treat 10 million mixed dyslipidemia patients with 4 gms EPA requires 15% of the worlds annual production of fish oil. Currently the internet price for pure DPA is $350 for 300 mgs of DPA. The reason why MTNB's trial size was so small. I know a about the pathophysiology of w-3s in regards to lipids and CVD risk..I am not very impressed with this 28 person study over 14 days. Amarin is running a study with 7500 souls which is entering its forth year, and we still do not have enough data..

    MAT9001 has got a whole book full of questions it has to answer before it eats anyone's lunch...Maybe its you that has your head in the sand..

    ": ) JL

    Sentiment: Strong Sell

  • jesse.livermore by jesse.livermore Jun 1, 2015 6:35 PM Flag

    Results seem great, but not really all that important. First of all stop the nonsense and tell us what's in the mix. DPA and other omega-3s ??? so MAT9001 lowers trigs more than EPA....So does DHA. PCSK9 ? what does significant mean if MAT significantly lowers PCSK9 over Vascepa, if Vascepa does not lower PSCK9. How are they going to source DPA...currently the stuff sells on internet at over $350 for 300 mgs. The company has only 3.5 mil in assets and some debt. How did they even afford the 4gm DPA trial, the daily DPA was costing them $4 k./ day, per person that was $80 K per day for the trial..No wonder they cut down on enrollment and stopped the trial.

    ": ) JL

    Sentiment: Sell

  • 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

  • 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

AGN
307.12-0.39(-0.13%)12:57 PMEDT