Amarin Corp Plc (AMRN)

[sts66]

The FDA is not going to nullify the SPA. They are simply going to delay it until ReduceIt is finished. End of story.

And end of AMRN - delaying SPA is the same as denying it as far as I'm concerned, dead money for the next few years, and I am royally PO'd about it - especially with the AH PR basically stating that yup, the FDA moved the bar midstream, no ANCHOR approval, SPA is officially reneged. WE ARE SCREWED. Lawsuit time for AMRN legal, no bones about it.

the U.S. Food and Drug Administration (the “FDA”) that the FDA has rescinded the ANCHOR study special protocol assessment agreement because the FDA has determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began. Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial

BS! Those trials were all halted BEFORE R-IT started!

which the FDA stated in its October 29, 2013 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL). Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.

Again I ask - WHEN WAS ANCHOR MODIFIED TO INCLUDE THE WORDS "REDUCE CV RISK"!?!?! AND WHO DID IT!?!?