J.L....."FDA will give Amarin advance review for as many as two promotional communications annually about off-label uses of Vascepa. Moreover, the agreement establishes a specific process for resolving any concerns that FDA voices about those communications prior to the parties returning to court."
My interpretation:.....Amarin informs the FDA of it's intent to do a promotional communication....the FDA agrees to do an advance review(i.e. before Amarin goes ahead and not a delayed review).....if the FDA approves, Amarin goes ahead with the promotion......if the FDA objects, Amarin and the FDA negotiate without going to court.
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