An "outcome study" as the AMRN CEO refers to, means..a study which measures "clinical outcomes" ie morbidity and mortality usually measuring clinical events or disease free state or survival..
The Omthera studies just measured the effect of Epanova on lab values of various blood lipids..That was not an "Outcomes Study".
The fact AMRN was required to do a very expensive and lengthy (six year) "Outcomes Study" on AMR101 is pretty strong evidence the FDA considers this drug an NCE...but we will see.\\