Amarin Corp Plc (AMRN)

[HDGabor]

M-

FDA took >500 mg/dl trigs to be a meaningfully distinct patient population for reasons relevant to V's patents.

Meanwhile TG below and above 500 - as a population - is relevant for LDL-C effect. FDA action is irrelevant.

(i) FDA approval was due to TG lowering effect... unrelated to LDL-C and Apo-B effects. TG 500 is a cut-off, when risk of pancreatis became more important than CV risk
(ii) FDA did not say anything about the patents ... FDA was not one "of the two separate federal agencies that informed or ultimately approved Amarin's patents".

Best,
G