Amarin Corp Plc (AMRN)

[HDGabor]

JL,

Not as a physician, but as a manager:

Current situation: Some doubt is exist regarding mineral oil, based on ANCHOR study. However other studies suggest that mineral oil does not have clinical effect, especially in this dose. FDA accept the mineral oil as placebo and they concluded that the best measurement of Vascepa is to compare to placebo arm. “Because no strong evidence for biological activity of mineral oil was identified, ultimately it was concluded that the between-group differences likely provided the most appropriate descriptions of the treatment effect of AMR101 and that whatever factor(s) led to the within-group changes over time in the placebo group were likely randomly distributed to all treatment groups.”

I do not see any reason now, to come to different conclusion in case of R-T. Based on this I do not see a necessity of the trial now. Based on current situation it will not necessary ever.

If anytime in the future – after interim / final result of R-IT or based on any other study - it will be necessary they will have enough time (before sNDA submission or AdCom, if any) to run this type of study.

My view: The real gamble is to run a trial now (result could destroy R-IT), meanwhile FDA did not request it, did not stated that eff. is definitely overestimated in ANCHOR due to mineral oil.

The result of the trial is ‘the answer for a never asked question / request’.