Amarin gets a boost from the FDA as reg­u­la­tors promise speedy Vas­cepa de­ci­sion — but what about that pan­el re­view?

There’s plen­ty of buzz to­day about Amarin $AM­RN and its quest to get car­dio out­comes da­ta added to the la­bel for Vas­cepa, its ther­a­peu­tic strength ver­sion of fish oil.

The FDA has giv­en their sN­DA pri­or­i­ty re­view sta­tus, leav­ing a de­ci­sion on open­ing up the mar­ket for this ther­a­py just 4 short months away on Sep­tem­ber 28. The move lops months off the reg­u­la­to­ry process and moves a po­ten­tial ap­proval in­to Q3 of this year — one of the biggest cat­a­lysts on the H2 cal­en­dar.

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