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  • Thoughts On Befuddled FDA AdCom  4 comments
    Oct 17, 2013 11:13 AM | about stocks: AMRN

    Vascepa was intended to reduce Trigs, which it did, safely and effectively, whether or not that translates to improved outcomes is unknown at this time.

    It should not be punished for not knowing the answer to outcomes, it does what it was asked to do, lowers Trigs and other Biomarkers, that is what it should be approved for with the label stating that no clinical outcome data is available to guarantee prevention of outcomes, but prevailing science feels that it is important to maintain healthy Trig and non-HDL-C levels.

    AACE was begging the panel to approve. It should be approved for this indication.

    Right now, Lovaza is the primary script written for ANCHOR patients, or off-label, and it comes with Atrial Fibrillation warnings and LDL-C raising concerns, neither of which Vascepa carries. Generic Lovaza could also be coming to market within a year or so, and that would likely be scripted to ANCHOR patients ahead of Vascepa for those Prescribers who don't understand all the details of the science and the warnings...

    Is this what you want to see FDA? You have to be out of your mind, and you ask "What if's" What if REDUCE-IT shows no benefit? Yeah, well how about THIS WHAT IF! What if REDUCE-IT shows dramatic benefit??

    WHAT IF REDUCE-IT SHOWS DRAMATIC BENEFIT!!! Then what do you say to all the Diabetic Mixed-Dyslipidemia patients who died while you held back a potential safe and effective LIFE SAVING THERAPY? WHAT IF?

    Use your head and listen to the prevailing science of the likes of the AACE who have thoroughly researched their field and have recommended therapy like Vascepa for those in need, those at risk.

    Disclosure: I am long AMRN.

    Stocks: AMRN
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  • rkd1961
    , contributor
    Comments (99) | Send Message
    That's why I think there's a good chance for approval, seems to me they would want to error on the side of safety. No?
    17 Oct 2013, 11:26 AM Reply Like
  • yazzbro
    , contributor
    Comments (628) | Send Message
    Yeah, this just wreaks of some corruption of some kind. The Adcom that was supposed to be about lowering trigs became an Adcom on Reduce-it in which the FDA knows in not even fully enrolled yet. Not sure what the FDA was trying to accomplish here. Also the Panelists obviously didn't do ANY research on the Anchor indications at all. They called Vascepa by another name. They called Reduce-It by another name. They clearly were very confused. And to change the question at the end was clearly unprecedented. AMRN had a snowballs chance in Hell with this Adcom. All the FDA accomplished yesterday was that they need more info on Reduce-It. Not sure why AMRN's CEO didn't stand up and say "Excuse me but we are here for the Trig indication and not Reduce-It" But he just kind of sat there with nothing to say. He probably should have just got up and walked out. But, too me this was some kind of corruption here. It's pretty clear of that. The FDA took the SPA and flushed it. They had AMRN go through hoops only to screw them in the end. AMRN racked up some pretty heavy bills to get this Reduce-It study rolling and the FDA pulls a fast one. Too bad AMRN can't do anything about. Must be nice for the FDA to know that there will not be any reprecussions for their antics yesterday. Just sad to see a drug that really could have helped people in the 200 - 500 Trig range be screwed. Also, if I am a Small Pharm co I would be very leary of any kind of SPA the FDA comes up with. Knowing that an SPA can be broken at anytime should worry any CEO having to go through this balony. What will end up happening is Pharm Companies will just stop trying to get FDA approval for the American Market. If I am small pharm with a good drug I would go for the European and Asian markets first and maybe just maybe try to bring it here. Really terrible what happened yesterday. Oh well I feel sorry for people that had a ton vested into AMRN. Those are the real people who got screwed.
    17 Oct 2013, 11:29 AM Reply Like
  • CarolinaCowboy
    , contributor
    Comments (30) | Send Message
    This seems to be exactly what that female panel member was pointing out when she wanted clarification on the voting question. She wanted the vote on the intended SPA, not on the future outcome of the additional R-IT trial. She KNEW that AMRN accomplished exactly what it was asked to do.
    What a fiasco, a sham, this entire thing is.
    By this ruling, ALL trig lowering drugs should be pulled (since they have not been asked to show their burden of proof of CVE) AND they all have safety issues.
    It makes one tend to ask, why bother tracking your trigs at all if this is the logic of the FDA.
    A downright shameful event.
    17 Oct 2013, 11:30 AM Reply Like
  • thestuntman
    , contributor
    Comment (1) | Send Message
    Thank God somebody gets it. Now can we investigate the individuals involved in yesterday's kangaroo court of a meeting?
    17 Oct 2013, 12:36 PM Reply Like
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