Amarin Corp Plc (AMRN)

[Atom0aks]

Can anyone link specific responses to his concerns
1) Increase in A Fib ...from what I remember there was no increase in strokes
2) Mineral oil ....does anyone remember the specific Dr Bhatt or AMRN response to that .
3) FDA wanting more than 1 trial

Further support that came out today which hopefully puts the mineral oil controversy to bed,

Alternatively, concern has been raised that the control arm of REDUCE-IT may have influenced the outcome of the trial. The comparator group received mineral oil, which itself raised hs-CRP by 32.3%, from baseline, resulting in a between-group difference at 2 years of 0.9 mg/L. Recent data from the CANTOS trial showed that a 1.6-1.7 mg/dL reduction in hs-CRP was associated with a 17% reduction in major vascular events.50 Thus, it is possible the magnitude of clinical benefit observed in REDUCE-IT could reflect a combination of both lower triglycerides and lower hsCRP in the EPA arm vs. the comparator arm of mineral oil, but even those two factors together seem insufficient. JELIS and DOIT were the only other two trials to test >1 gram/day of EPA and both had CV risk reduction beyond what was expected based on non-HDL-C lowering, supporting the potential pleiotropic benefits of higher-dose EPA.

Source: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.041998