I'm not a lawyer, as well as you, and our answers to the question are nearly worthless. That said I think they could do this step. As you said in another post of yours "I don't think this question has come up in a court of law before" none actually knows what can be and what can't be the judge answer.
FDA was (and will be) within the legally allotted times for their answer during the appeal process. However, if not the Performance goal is: 90% of such answers are provided within 30 calendar days of the Center’s receipt of the written appeal. To sue FDA as "bad faith on the FDA's part" is ...
As you cited "This is perceived to reduce risk by eliminating the fear that a positive outcome in Phase III might not result in approval if the trial design is not acceptable to FDA.".
FDA did not breach the SPA with rescission, since the director of the review division entitled by the statue "to determine that a substantial scientific issue essential to determining the efficacy of the drug has been identified after the testing has begun".
Amarin could sue the FDA for:
a.) timing of the determination - they can win this argument as the action was not within a reasonable period of time after FDA becomes aware of the cited studies, the basis of their new approach for biomarker based approvals
b.) the determination by the director of the review division is wrong - as it's science (and TG isn't a validated surrogate endpoint) it's not black or white (more details: #34685)
It could be less time (by app. 6-9 months) IF R-IT will goes till the end, if interim result won't be good enough to stop the study. Based on JL's great assumption it is more likely that the study will be stopped after interim analysis in 2016.
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