Well, Leerink is wrong. I stand by my call that the FDA notified Amarin that there was problems with the NCE status, then Amarin requested this meeting to protest.
It is NOT a good sign. You think such a rare meeting with high level FDA legal reps is a good thing one month before the PDUFA over the status of exclusivity? I think not.
I dont question whether or not it gets approved, but I do question the NCE status. I think there is only about 25% chance Amarin gets it. Previous precedents do not apply here.