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drrc1949

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  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    I guess I have a problem understanding the relevance of whether Clinician Scientist owns any stock in Amarin or not. His article was a fair evaluation of the factors that the FDA claimed led them to conclude that new science was responsible for rescinding the AMRN SPA. The FDA and Amarin jointly agreed on the parameters governing the SPA including the requirement to "substantially populate" an outcomes trial (Reduce-It) prior to submission of the ANCHOR sNDA. The SPA created a contractual obligation between the parties and was only to be broken if the sponsor did not perform or if safety factors arose during trial or "new science" challenged the efficacy of the sponsored drug - Vascepa.

    Anybody see any "new science" here? Did Amarin fail to deliver on ANCHOR results? Is there an outcomes trial populated at nearly 75% of the 8000 total? Are there some safety issues we need to know about? Or is it just that the Director of the FDA has a proverbial hair up his or her proverbial SSS for Amarin? Lots of questions.....by default, only the last one deserves a "Yes".

    And who really gets screwed here...the patients! I am a [patient and I need this drug to treat my TGs and provide its other benefits to improve my health. Unfortunately, I am not wealthy, so as is the case with so many other drugs, I need Vascepa approved so some of the cost is absorbed by my insurer. That's why I pay the exorbitant premiums every month...thank you very much!
    Nov 19 06:35 PM | 4 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    There was the JELIS Trial though Cora which the FDA does not give credence to but which demonstrated clinical benefits for even those subjects with TGs under 200mg/dL but with mixed dyslipidemia. There's just too much evidence out there to place treatment restrictions on TG levels over 199mg/dL.
    Nov 19 05:36 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    "Alphaplay", you've got that wrong. The indication sought by Amarin was for High TGs from 200mg/dL to 499mg/dL. That's the cohort the FDA now says will not benefit from TG treatment. If it were the borderline group under 200mg/dL, I'd almost be in agreement with you. But there's no clear rationale why they would restrict those with High TGs.
    Nov 19 05:23 PM | 3 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    PSalerno, are you confusing FDA with FDR, they are not the same person!
    Nov 19 05:00 PM | 2 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    "Think-first", I'm very much in agreement with your thoughts on this article, it is a well-crafted, reasoned and truly informative piece. I too wondered about the conclusion related to Omega-3s that was posited by this new FDA position on Triglycerides. I suppose I could go along if I never had to eat another salmon steak, BUT, I've already studied the actual results of far too many clinical trials to believe that Omega-3s, particularly the EPA type that's used to produce Vascepa, had no cardiovascular benefit.

    Frankly, the more I read, the more I believe that the benefit of EPA goes far beyond reducing TGs and that anti-inflammatory effects at the cellular level will prove to be the real benefit of this drug class by directly preventing or improving vascular damage that leads to Atherosclerosis. There is a growing mountain of evidence in peer reviewed journals that supports this likelihood.

    Unfortunately for many Americans, this type of outcome and pronouncement from the FDA just shows me there's a lot of ignorance and arrogance throughout that agency. And they are empowered with decision making authority that can keep very beneficial treatments out of our reach. I don't know how much influence you or I can really exert in a case like this but something needs to be done! Maybe this is a job for Congress, at least there's a chance that both sides of the aisle will be in agreement.
    Nov 19 09:45 AM | 13 Likes Like |Link to Comment
  • AMRN: Does The FDA Need To Be Investigated  [View instapost]
    ralphie, just wanted to let you know I read your article in its entirety and really enjoyed hearing your perspective, that of a practicing clinician. I too am long AMRN and have immersed myself in the science behind Vascepa, to the full extent of my ability to grasp it. It certainly does appear that from the point of view of the FDA, something went seriously awry with the Anchor AdComm. They definitely conveyed the message that there is no longer a reason to treat high triglycerides and that they will not approve any new treatments for that purpose unless there is evidence of a reduction in CVD attached. It makes no sense to me because there is no new science on which to base these conclusions. So there must be some other motivation at play here and it seems we'll need to wait until the FDA decides to reveal exactly what that may be.
    Oct 21 10:20 PM | 5 Likes Like |Link to Comment
  • All Eyes Now Focusing On Acquisition Of Amarin [View instapost]
    Steve, I am a devoted acolyte of Vascepa.......Amarin???, not so much....

    I provided some information and posed several questions to the company through IR email and snail mail but received no feedback. I can understand that, they're a small company after all. Likewise I tried the message board route which generated some lively discussion but no clear answers. Late yesterday, I discovered that you had returned and I've just finished catching up on your blogs and comments .

    Although Omthera/AZN hold no Omega-3 patents directly, DD published elsewhere by Biobillionaire reveals that Omthera has one application for Epanova in enhancing the effects of Clopidgrel anti-platelet therapy. Additionally,Omthera has a license agreement with Chrysalis Pharma who has 4 EPA related patents. Two of these are for capsules and two are for treatment of Irritable Bowel Symptom, a major inflammatory condition.

    I concede that acquisition of Omthera by AZN might just be a play for a combo drug with Crestor. But I can't stop wondering if something more may be at play here. AMRN longs have been made aware of the EPA:AA ratio and its potential impact on overall health. It's the basis for the huge breadth of potential indications for Vascepa, specifically due to its anti-inflammatory effects.

    Is there a chance that AZN is initiating a formidable end run with the Omthera product, perhaps in a modified form, by focusing on securing patent protections not contemplated by Anchor? AMRN has done all the legwork but the target has been treatment of lipid disorders. If AZN becomes the first to file claims that laser focus on EPA anti-inflammatory benefits, does Vascepa lose out to the AZN Omega-3 product? Does the current or applied for Patent Wall protect AMRN/Vascepa from this direction of attack?

    Or maybe AZN did, in fact, just buy a bargain entry point into the lipid space. Thoughts?
    May 29 06:54 PM | 1 Like Like |Link to Comment
  • Amarin (AMRN -0.6%) lags the general market after being being given a less than enthusiastic initiation by analysts at Chardan Capital Markets with a Hold rating and a price target of $8.50 a share. The firm says that the chance for a strategic deal over the near-term is low, and Vascepa faces risks of a tepid debut. [View news story]
    The array of inept sources of information relied upon by these analysts amazes me. Quote: "A survey showed curbed enthusiasm for Vascepa and an undifferentiated clinical profile compared to three other therapies" - Unquote. Where did you find this survey.....on Family Feud? I'm retired but looking for part-time work.....can HR from Chardan Capital Markets please contact me? I think I have what it takes to make it as one of your crack analysts!

    If your "analyst" had spent 15 minutes researching Vascepa, he/she could not possibly have used the above quote as it is blatantly misleading at best. I will not attempt to make the case for Amarin's success or failure. BUT I will state that if this is the best you've got, then Chardan Capital Markets should start developing a New Business Model. You're not gonna make it at this!!
    Mar 21 07:15 AM | Likes Like |Link to Comment
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