Amarin Corp Plc (AMRN)

[Biobillionair]

Regarding Ad Com:
“The window is closing”... the window is closed IMO ... FDA would need to break the glass fo an Ad Com.

https://www.fda.gov/advisory-committees/advisory-committee-calendar

PDUFA dates out to 9-27-2019 where assigned Ad coms a week ago, and the Omega document released by the FDA clearly shows the FDA has thought this through and determined to increase DS daily max intake to 5 grams of fish OIL per day.

It’s unlikely the FDA convenes an Ad Com for R-I label expansion. A R-I Ad Com might be convened in the future but that will discuss other indications like Alz, NASH, and perhaps more....

JMO
BB