Yes, you're right, but it depends on the case. Regarding this one, surely it is unprecedented, and then you must consider that "science" and the evaluation of "scientific issue" is involved, and a judge probably won't decide on this kind of matter without experts' hearings and s.o.
Amarin could sue the FDA after the final denial by the Commissioner. 2(3?) level is remaining till that and one level is at least 2 months, but could be 5. The final denial could be expected around March 15 and the case could be filed in April as the earliest.
Amarin has two basis: a.) FDA’s approach is wrong. It’s a science dispute. b.) the timing of the rescission. It’s the stronger, since FDA has 2 years after Accord-Lipid AdCom, however if the period counted from the date of the submission … (sorry, it’s a new think. I do not like it also)
The final ruling date (mid-2017) is just a guess from me, however do not forget that it could be more than one round / court if the first ruling will be appealed. ie.: Ivy vs FDA first round was 2 years!
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