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ganj1948

ganj1948
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  • Amarin: Today's Market Is Underestimating The Probable Success Of REDUCE-IT [View article]
    Thank you for the info.
    Dec 17 11:35 AM | 1 Like Like |Link to Comment
  • Amarin: Today's Market Is Underestimating The Probable Success Of REDUCE-IT [View article]
    Biwatch, great article. I have one question that I have asked others without success. I know that REDUCE-IT is looking at 150 to under 499 trig levels with the median over 200, whereas Anchor only looked at over 200. Will the subgroup of 150-200 be separated out as a subgroup for analysis purposes or will they be aggregated with the higher trig group? My concern here is that the inclusion of the150 to 200 trig group will make it less likely to have the relative risk reduction that you need (albeit vastly increasing the possible patient population that could be approved for Vascepa).
    Dec 16 04:08 PM | Likes Like |Link to Comment
  • Amarin Makes A Potentially Attractive Medium-Term Investment [View article]
    I think that because rescission of a SPA by the FDA is such an extremely rare event that there is very little legal precedence. Amarin management team no doubt is in full panic mode, but I think that they should get a pass on procedures here.
    Nov 22 05:06 PM | Likes Like |Link to Comment
  • More on FDA - Amarin [View news story]
    The Anchor SPA was not for reducing CV's. The SPA required the outcomes study, Reduce-It to be substantially underway. Since this condition was met, the FDA should have worded the AdCom question to reflect this, not whether Anchor provided proof of reducing CVs.
    Nov 22 03:37 PM | Likes Like |Link to Comment
  • Amarin Makes A Potentially Attractive Medium-Term Investment [View article]
    This appeal was temporarily denied due to a procedural issue only. It was a chain of command, legal issue. There will be another appeal filed and it eventually will be heard. It is extremely doubtful that it will be totally successful, but any kind of label expansion will help the battle against Lovaza and increase the odds that Reduce-It will reach its conclusion.
    Nov 22 02:07 PM | 1 Like Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    If I am reading this correctly-what you are saying is that because the FDA violated Amarin's SPA by asking the wrong question at the AdCom that the AdCom's negative vote is justification for rescinding the SPA. Legally the SPA was still in effect at the AdCom as notice was not given to Amarin until afterwards.
    Nov 20 08:29 PM | 2 Likes Like |Link to Comment
  • Amarin's Q3 Call Points To Dark Days Ahead [View article]
    These negative studies were so far removed from Vascepa as to be irrelevant. Even so, the sub group from the ACCORD-LIPID study that had trigs over 203 and HDL-C under 34 (which is the same mixed dyslipidemia that Anchor studied) had 40% fewer CVD events compared to the placebo. The p Value for this subgroup was .057, only .007 from statistal significance of 95%.
    Nov 8 02:10 PM | 2 Likes Like |Link to Comment
  • Class Action Lawsuit Filed Against Amarin Corp: Shorting Opportunity? [View article]
    One of the FDAs problems with the Jelis study was that the patients were not taking the optimized level of stains (too low a dose). The HPS2-THRIVE results stated "Asian subjects are also recognized to have higher blood levels than Caucasians following a given statin dose." And this quote about the same study "They enrolled 10 000 patients in China, but if you talk to any clinician they will tell you that Asiatic patients tend not to tolerate either niacin or high-dose statin therapy," said Dr. Steve Nissen, Cardiology Chair Cleveland Clinic. "And of course that's exactly what they saw. This was a mistake." From another study "Plasma exposure to rosuvastatin and its metabolites was significantly higher in Chinese, Malay, and Asian-Indian subjects compared with white subjects living in the same environment." In other words, if the Jelis study used the "optimized" statin levels suggested at the Amarin ADCOM, the patients may have exhibited serious side effects from the statins that were found in the HPS2-THRIVE study which found the Chinese patients in the study were 4 times more likely to experience myopathy than the European patients.
    Nov 6 11:07 AM | Likes Like |Link to Comment
  • Class Action Lawsuit Filed Against Amarin Corp: Shorting Opportunity? [View article]
    The data from one of these studies, ACCORD-Lipid showed that the mixed dyslipidemia subgroup in the study had a p value of .057. This was only .007 from statistical significance and almost certainly would have been if the patients in this subgroup were higher (less than 1000 out of a total over 5000). The study showed that those in this subgroup who were treated with fenofibrate and a statin had a 40% decrease in CVDs compared to the placebo group of statin only (12.37 vs 17.32). The FDA is selectively using data and ignoring the most relevant data. The study overall was not significant, but the subgroup that Anchor and REDUCE-IT are targeting was.
    Nov 5 12:19 PM | 3 Likes Like |Link to Comment
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