Amarin Corp Plc (AMRN)

[HDGabor]

As you agree, FDA won’t drop the lipid approach and won’t focusing on inflammatory for many, many years, why you think (why I am wrong) that after successful R-IT, TG won’t be validated as surrogate endpoint and FDA will care the secondary endpoints, lowering inflammatory biomarkers.

It looks like for me that FDA will approve any drug based on validated endpoint(s) only. As Vascepa is not “LDL-C drug”, TG or inflammatory biomarkers have to be accepted for approval.

Based on your (and JL’s) post I still think that after successful R-IT, TG will be validated as surrogate endpoint (FDA does not care inflammatory biomarkers currently) and new TG lowering drug could refers to R-IT and could get approval without own CVOT.