Amarin Corp Plc (AMRN)

[sts66]

The official label won't be known until PDUFA, but the AC will be voting on a proposed label, just as they did at the ANCHOR AC. The proposed label is likely identical to what AMRN asked for in the sNDA, since JT reiterated in the CC that they still haven't started label negotiations with the FDA. Don't want to add to existing conspiracy theories, but assuming AMRN asked for a broad label and the AC voted yes, R-IT results support it, the FDA could still meet with AMRN and say "we want a narrower label" (AC votes are not binding) - I don't see how JT could win that argument if FDA stands firm and says "it's this or nothing" - AMRN needs the R-IT label whether it's narrow or broad. That said, I think the chances of that happening a slim, but they're not none - I know there have been instances where the FDA granted a label different from that asked for - the ones I recall went both ways, some broader, some narrower. But hmmm.....not sure those occurred after an AC or not.....pretty sure at least one for a broader label came before an AC because the FDA teased subgroup results out of the data in the NDA that the sponsor had missed, or they didn't ask the label to include that specific subgroup.....believe it was a cancer drug.