Summed up good... (In my opinion, there are strong parallels here to Fifth and Fourteenth Amendment protections against government “taking” without legitimate government interests and without fair compensation.) --- IMO likely the reason behind the delay, unfortunately delay digs the hole deeper.
Everyone overlooks FDA MUST have science base to rescind the SPA...there's no such evidence available for VASCEPA. Other drug evidence is not applicable under PDUFA law/guidance. This also holds true for indication, no new Scientific evidence has arisen to refute the dangers of High Trigs...quite the opposite has surfaced prior to the FDA's decision to rescind.
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