Amarin Corp Plc (AMRN)

[sts66]

4) In a November 1, 2004 facsimile to Lovaza's sponser, FDA noted that the sponsor had requested that the established name for Lovaza be changed from "omega-3-acid ethyl esters" to a combination of ... two main components of Lovaza, EPA ethyl ester and DHA ethyl ester. FDA rejected this approach, noting that the sponsor's proposed name did not correspond to the drug substance of Lovaza, as it "implies that there are no other components to the drug substance, when, in fact, there are."

IIRC, the Fuson CP was another attempt to get the FDA to overturn that decision - and the FDA denied the CP *and* denied V NCE on the very same day. Covington used those actions as part of it's argument in the NCE court case - they are two absolutely conflicting decisions by the FDA, which is why FDA should lose the case.