Amarin Corp Plc (AMRN)

[HDGabor]

no NCE, that will signal

If "no NCE" signal anything it is fine for me, since AMRN will win the case, as

FDA declined NCE since the active moiety of a complex mixture is not the mixture itself and EPA was approved “as Lovaza”. This approach was used by FDA at the first time in case of Vascepa, however I am not going into the details (it could be one reason to overturn the decision, but the argument below is the key).

FDA declined all previous NCE if the active moiety was approved earlier, however the active moiety as a factor for NCE was determined in FDA own regulation and the statue contains the determination of “active ingredient”.

FDA agreed with Amarin that Vascepa and Lovaza have different active ingredients, Vascepa and Lovaza undisputedly have different active ingredients.

Statue is stronger than regulation, could not be override.

The court will overturn FDA decision and will grant the NCE (at least based on ingredient:moiety – statue:regulation) as it were happened in the past (and as it were for USPTO also).

Some supporting doc links in #30800