The only thing the FDA has to offer is a label change. If you have another suggestion, I'm all ears.
How about not requiring AMRN to get FDA approval for an future off-label promotional statements? Although I can't see how the FDA would agree to that, they would lose all control over AMRN - untenable position for them IMO. This is the only thing I can think of that's a real reason for the delay - talks of looking at R-IT data, getting ANCHOR label, SPA reinstated, etc., are all off base IMO.