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Isis Pharmaceuticals, Inc. Message Board

jetmanbash 236 posts  |  Last Activity: 13 hours ago Member since: Dec 29, 2004
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  • Re: Two years later and with a head start as the Clara Pela would say, 'where's the beef Mr. juxta?"
    Is it time for the FDA to look into pulling juxta from the market? I think it is very close. The data that comes in for juxta should be considered Phase IV data. The drug was approved conditionally based on future studies. It got a free pass because there was nothing else when it was first approved. Well we know from two years straight data that Mipo does what it is supposed to do and IMO does it convincingly with a trend that is IMO remarkable based on the known very poor prognosis in this particular population. Does juxta have such data? I don't think so. If the drug doesn't work as intended, may cause damage, and there is another product out the that does work for a much cheaper price I think that juxta should be demoted like the antibiotic Trovan was to where the FDA puts further restrictions on its use. In other words, only under really extreme circumstances should the drug even be used at all, or if ever if it can not support CV event reduction. Dr. Beer will probably be wrong again in regards to approval in Germany....it was only a formality(according to him) before the drug received approval in Germany? Don't think so. The public should be protected, where is the efficacy data at the two year mark with a way more than the 23 patient study in regards to how the drug performs in the real world?

    Addendum to above: If there is no such data to support the indication for the drug as intended the price at most should be $1000 per month....actually on the high side but it is a wounded orphan drug after all. t

  • If you want to get a stock quote you only have to use your left hand!! t

  • Two years later and with a head start as the Clara lady would say, 'where's the beef Mr. juxta?"
    The role of microsomal triglyceride transfer protein inhibitors in the treatment of patients with familial hypercholesterolemia: risks, benefits, and management
    Current Atherosclerosis Reports, 11/20/2014 Clinical Article

    Ahmad Z, et al. – The data suggest that the cardiovascular benefit of MTP inhibition remains unclear. However, microsomal transfer protein (MTP) inhibition offers a viable additional lipid–lowering option for patients with homozygous familial hypercholesterolemia.

    IMO another nail in the coffin labeled: For HoF patients who fail on Kynamro only. After two years data the supposedly superior drug can't even show for sure any clear-cut CV benefit......much less show that it is superior to Mipo. I would think well-intended lipidologists would reach for Mipo first. Better drug for what you are treating AND a cheaper price. If this were the real world with a high volume medical product a deep discount in the price of juxta would be in order. t

  • jetmanbash by jetmanbash Nov 20, 2014 8:57 AM Flag

    vicl closed yesterday only eleven cents from its yearly low. This with the stock market continuing to mark new highs almost every day. We here at the VNN are attempting to get a list of all employees and help them seek new employment positions once the company does go BK.....except for the CEO who apparently has found a job as a luxury cruise liner captain over in Italy. t

  • jetmanbash jetmanbash Nov 19, 2014 9:05 PM Flag

    I don't think you could hold a candle to bcpiii. t

  • jetmanbash jetmanbash Nov 18, 2014 11:12 PM Flag

    The table shows it all:

    In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO. MACE were defined as myocardial infarction (MI), stroke, unstable angina (UA) and revascularization procedures (PCI/CABG).


    Event
    Number of MACE in
    patients two years prior to
    treatment with KYNAMRO

    Number of MACE in
    patients after two years on
    treatment with KYNAMRO
    MI 39 2
    PCI/CABG 99 6
    UA 5 4
    Stroke 3 0
    Total 146 12

    MACE rate
    (per 1000 patient-months)
    p

  • jetmanbash jetmanbash Nov 18, 2014 10:13 PM Flag

    Part II:
    n this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO. MACE were defined as myocardial infarction (MI), stroke, unstable angina (UA) and revascularization procedures (PCI/CABG).

    Event Number of MACE in
    patients two years prior to
    treatment with KYNAMRO
    Number of MACE in
    patients after two years on
    treatment with KYNAMRO

    MI 39 2
    PCI/CABG 99 6
    UA 5 4
    Stroke 3 0
    Total 146 12

    MACE rate
    (per 1000 patient-months)
    p

  • CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--

    Genzyme, a Sanofi(SNY) company, and Isis Pharmaceuticals Inc.(ISIS) , today announced that new two-year data from a phase 3 long-term extension study of KYNAMRO® (mipomersen sodium) injection was presented at a scientific session at the annual American Heart Association meeting in Chicago, IL. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events (MACE) compared to two years prior to therapy.

    “This analysis is very encouraging as the rate of MACE declined sevenfold after two years of treatment with KYNAMRO in patients with homozygous and heterozygous familial hypercholesterolemia (FH),” said Dr. John Kastelein, M.D., Ph.D., professor of medicine, chairman of the department of vascular medicine, Academic Medical Center, University of Amsterdam. “This analysis represents an important finding and supports the potential for further study of the therapeutic benefit of KYNAMRO in patients.”

    This retrospective analysis included 104 patients who enrolled in the long-term extension study of KYNAMRO after having completed one of the KYNAMRO phase 3 blinded, randomized, placebo-controlled 6-month trials in patients with homozygous and heterozygous FH. All patients who completed at least two years of treatment with KYNAMRO were included in the analysis. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO.

  • jetmanbash jetmanbash Nov 16, 2014 11:24 AM Flag

    Agree with you YG. There are so many deals upcoming. One in particular is really secretive for competitive purposes. t

  • Reply to

    Number of LD patients

    by archie_barchie Nov 9, 2014 6:48 PM
    jetmanbash jetmanbash Nov 15, 2014 10:50 AM Flag

    XOMA, and AVNR do look to have some potential in regards to products and high implied volatility. And my favorite ISIS with their ApoCIII drug that lowers triglycerides by 75% and raises good HDL by 55%. Good luck in whatever you do. t

  • Reply to

    Another feather in Mr. Beer's cap:

    by jetmanbash Nov 11, 2014 9:10 PM
    jetmanbash jetmanbash Nov 14, 2014 11:50 AM Flag

    Next move probably will be a shelf offering in order to have some cash to develop and market the new drug. for all of his bragging when the company first started Mr. Beer has certainly made a mess of things IMO. t

  • Reply to

    Very latest press release from RNN:

    by jetmanbash Nov 13, 2014 9:44 AM
    jetmanbash jetmanbash Nov 13, 2014 11:06 AM Flag

    Shareholders will be making more money than you are just talking. t

  • Reply to

    Very latest press release from RNN:

    by jetmanbash Nov 13, 2014 9:44 AM
    jetmanbash jetmanbash Nov 13, 2014 11:05 AM Flag

    I thnk it does seem to be showing a wide therapeutic index with very little side-effects to allow them to do this. t

  • Rexahn Pharmaceuticals reports Q4 EPS of ($0.01) vs ($0.03) single estimate (0.71)

    "Data from the ongoing clinical trials with Supinoxin™, RX-3117 and Archexin continue to look encouraging and we are pleased with the continued progress of our clinical development programs. Significant Supinoxin and RX-3117 exposure is being achieved in cancer patients without signs of dose-limiting side effects. As one of the primary outcome measures from these trials is the determination of the maximal tolerated dose (MTD) these positive safety results require that we continue testing additional higher doses of Supinoxin™ and RX-3117."

  • jetmanbash jetmanbash Nov 13, 2014 12:15 AM Flag

    Why be so snoopy? Let the people who know science and believe in the company make their bets. No one is God, it is risk, everyone knows that. Go about your shorting business and let others do their own thing. I don't care where a stock has been, I care about where it is going. Your snide remarks when you are "trying" to make an accurate account of what was said doesn't improve your credibility. Don't be a Gladys Cravitts, and just short to your hearts content. t

  • Reply to

    Another feather in Mr. Beer's cap:

    by jetmanbash Nov 11, 2014 9:10 PM
    jetmanbash jetmanbash Nov 12, 2014 4:07 PM Flag

    I tried to copy it but it wouldn't copy. From the SEC this time and relates only to $300K that the SEC states was added to earnings.....In any case I wouldn't want the SEC checking out my company for anything. Will try and post it later tonight. t

  • SEC opens new investigation of AEGR.

  • jetmanbash by jetmanbash Nov 10, 2014 2:13 PM Flag

    Mr. Beer spent almost all of the cash. He will have a new drug to develop without any help from the seller, AZN made it clear in their news release that NOTHING was going over to AEGR in this sale. No employees, and no facilities. Mr. Beer is back to the old trick of looking for more patients with the lipiddystrophy. Mipo is starting to eat their lunch, you have competition coming in from PCSK9 inhibitors, you have Esperion as a dark horse to eat into some of the sales possibly. You expense in Japan to complete a study. Problems with Brazil, and very possibly other parts of the world. You have 1st generation lawsuits, and you have second generation lawsuits. You could at any time hear about the dismissal of Mr. Beer. You have an overpriced drug set up in the model of DNDN that just went bankrupt today. You have a 36% discontinuation rate with the drug that is being propped up by personal dietary trainers.........my kind of company...not. Wait for Mr. Beer to announce another study to dig up more new patients for the new drug, which by the way seems almost too dangerous to use except in the really dire patients. t

  • jetmanbash jetmanbash Nov 10, 2014 8:29 AM Flag

    A remark like that shows that you aren't too familiar with what is going on. The Dutch, French-Canadians, and South Africans have some of the highest genetic lipid elevations in the world. He has a vast amount of experience with the drug. Over time you will see, keep on buying the company like your strong buy recommendation says. t

  • Reply to

    Number of LD patients

    by archie_barchie Nov 9, 2014 6:48 PM
    jetmanbash jetmanbash Nov 10, 2014 8:26 AM Flag

    He should have bought out DNDN for a cheaper price with potentially more patients to treat. t

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