Amarin Corp Plc (AMRN)

[jessellivermore]

After the AdComm...after the SPA recission.

At one of the CCs the subject of Amarin's dialogs with the FDA came up. My recollection is that either JT or Amarin's lawyer responded. The ANCHOR trial was run solely to determine whether: 1) Could Vascepa lower trigs in the 150-500mg/dl group; 2)Could Vascepa accomplish this lowering without raising the LDL-C. The FDA considering the LDL-C levels the primary biomarker. The problem with other trig lowering drugs is they did significantly raise the LDL-C. Since the FDA had previously signed off on these two requirements, the only remaining requirement was that Amarin design an FDA approved "outcomes study" and the study be "substantially underway".

The question was asked since the ANCHOR SPA made no mention of the efficacy of V treating CVD events how could the FDA withhold the sNDA (labeling for the mixed dyslipidemia indication) and had the company somehow angered the FDA by insisting the FDA allow a label that said the drug was effective for lowering CVD events. The company denied this. In fact they said that they had themselves suggested such a compromise. This led to a series of posts on this site about "black box" warnings etc..

":>) JL

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