Amarin Corp Plc (AMRN)

[HDGabor]

Lovaza study was referred as other omega-3-acid study, not as a minerail oil placebo study. Lovaza decreased TG levels by 26% to 47%, whereas corn oil placebo increased them by an average of 6.7%.

Furthermore FDA did not attack the mineral oil as placebo, does not penalizing AMRN for it. They checked the placebo arm (due to strange lipid changes) and during this analyzes among with other possibilities, they check the mineral oil also.

"Thus, the review team sought evidence that might help explain the changes observed in the mineral oil group. These included considering the plausibility that treatment assignment could have been unmasked due to physical differences in study drug appearance or manufacture; reviewing the literature for mineral oil-specific effects on lipid parameters or absorption of fat-soluble vitamins; evaluating whether the statintreated subjects in the placebo group from MARINE demonstrated a similar pattern; and considering elements of the ANCHOR study design that may have contributed. Finally,the Division reviewed lipid changes observed in the placebo groups of other lipidlowering trials."