Over past 48 hours I have referenced several FDA attorneys as well as the work of a biochemist that wrote the actual patent data found in Amarin's key composition of matter patent. I am very confident that AMRN will gain NCE status based on FDA characterizing the active moiety different than that of Lovaza. On its face, it appears a close call and fairly complex since Lovaza is made up of DHA and EPA. However, FDA has decided that that combination of those elements work as ethyl esthers. Once you understand the mechanism of action and what AMRN found with their compound that Lovaza did not, it actually becomes much more clear. Currently, the FDA does not have any approved Rx containing icosapent ethyl alone or in combination as active moiety. The key is icosapent ethyl and it is not found alone or in combination. Period.
Well thanks for the comment little helper... But the issue is that the combination that Lovaza has ..you said "half the ingredient" is not currently approved in regards to NCE by ITSELF. That's the issue..When used alone as in Vascepa, it will qualify for NCE...because the combination can only GET NCE if NONE of the parts of the combination individually have gotten NCE status...which they have not or else LOVAZA would not have gotten that status, but they did...so each individual part has not gotten NCE by itself...along comes Vascepa....and here we go. "Thanks for the comment though..." anyone else?