Amarin Corp Plc (AMRN)

[HDGabor]

The case similar, but not the same:

- as I know (could not find, it was withdrawn in 2010) no existing guideline for lipid-altering drug trial for primary end-point
- FDA 'realize' the new sciense in BD only
- new sciense is based on different population ("Subgroup analyses from JELIS, ACCORD-Lipid, and AIM-HIGH suggested that patients with elevated TG and low HDL-C might experience a greater potential treatment benefit with additional lipid modifiers to a statin regimen; however, the available HPS2-THRIVE subgroup analyses do not seem to support this hypothesis. Unfortunately, none of these trials were specifically designed to recruit and investigate patients with moderate hypertriglyceridemia with or without low HDL-C; therefore, these results are hypothesis-generating and require validation.)
- new sciense based on different type of drug studies (Triplix EMDAC: "no additional relevant clinical evidence provided by ACCORD-Lipid")
- FDA did not follow any protocol (ie.: determination of new sciense is not equal with rescission of SPA)
- Senate / House involvement
- several CPs