Amarin Corp Plc (AMRN)

[sts66]

I believe this ADCOM will be about introducing other biomarkers (EPA/AA, hs-CRP) as acceptable surrogate end points to approve drugs for CVD reduction

Not the time or place to do that, especially given lack of full understanding of EPA's MOA, and FDA has essentially said "no more surrogate biomarkers for showing reduced CVD risk, you must run a CVOT", I doubt that attitude will change. In any case, hsCRP would be a crappy one to use, it's affected by way too many other things besides CVD, and CANTOS showed that lowering hsCRP did not reduce 3-pt MACE except for a subgroup of "responders" that got levels < 2 (analysis was post ad-hoc), so FDA gave NVS a CRL for their sNDA. I think Lp-PLA2 levels will eventually become a widely accepted risk marker used by clinicians, assuming R-IT shows a correlation between levels and event rates, but that will just be a screening tool, not a new surrogate marker for FDA indications - same thing for EPA/AA ratio.