I suspect they’ve tried to get something approved in this arena. Since nothing has come of it, I suspect FDA is again keeping AMRN from promoting anything other than high TGs.
I do not suspect anything, but I do not think that new element of off-label promotion (if any(thing was requested)) should be disclosed (PR or 8-K).
I am certainly sure that if FDA is trying to keep Amarin from new, requested off-label promotion (acc. to the settlement agreement) Amarin will go back to the court w/o any hesitation.
Furthermore, the outcome of the ITC won't affect the off-label promotion / settlement.