Wednesday, March 19, 2014 11:58:37 AM
That said, their total strategy is essentially trying to salvage
the Co. through litigation, ie, 1st Amendment, NCE, and suing the
FDA over Anchor. After over 20 years in this Sector, including 10 years consulting for FDA, I can't think of one Co. that prevailed at the end of the day, by going into hand to hand combat against FDA. I have great respect for you and your work, but let's agree to disagree. This could have been all been avoided if Thero would have
compromised with Agency when the SPA was put back on the table.
That was all FDA wanted, saving face and revising the SPA. It would
have allowed AMRN to basically still market Vascepa for Mixed Dyslipidemia, with the tacit agreement to acknowledge, that there
was no data as yet to prove that lowering Trgs improved Patient Outcomes, and make the SPA contingent on Reduce-IT RESULTS. That
would have been a win/win for both AMRN and FDA. Thero played hardball, and by refusing to compromise, FDA was rightly angered and
pulled the plug again by rescinding the SPA a second time. A basic dictum in Biotech is you don't fuck with the FDA.
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