JL, I've read and re-read all of the posts that argue the validity or duplicity of the FDA decision to rescind the Anchor SPA. I can't think of any language that could further clarify YOUR argument that the FDA violated the SPA agreement, a contractual obligation requiring Amarin to initiate and substantially enroll Reduce-It, a CVD outcomes study (at a cost of over $100,000,000.00) in exchange for the FDA granting a favorable indication for the Anchor sNDA (expanded sales opportunity for Amarin). The agreement was conditioned on safety (no issue) and efficacy defined as the ability of Vascepa to lower triglycerides in a patient population.... PERIOD!!!!
If this case were to be presented in a Court of Law presided over by a fair and impartial judge, I believe there is no doubt that Amarin would prevail over the FDA. My fear is that Amarin will once again "pull the short straw" and find themselves dispatched to another hostile arena. One more bad outcome, but from your reference to the message that was left by your Amarin Rep, I sense you might agree the better play for Amarin right now is to turn the tables on the FDA..... become a Defendant in a 1st Amendment case rather than an ad infinitum Plaintiff vs the FDA.
I believe Amarin should make a significant investment in the preparation of a high profile informational pamphlet that quickly identifies the key benefits of pure EPA based on the most current, relevant peer reviewed trials and investigational science. Hand it out or mail it to every Cardiologist, Endocrinologist or Lipidologist that they can identify and let the chips fall where they may! If the FDA has a problem with that, then let them come. We investors could elicit help from the EPADI and together we can surely find ways to encourage the Media to cover that story? Lots of interesting hooks there! ....Just My Opinion
