Amarin Corp Plc (AMRN)

[MedResCollab]

the window is closed IMO ... FDA would need to break the glass fo an Ad Com. 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. -Biobillionaire

Incorrect. The window is wide open. You may start feeling more confident as we enter into July.

The day 74 letter likely included preliminary plans to hold an Advisory Committee (AC) but gave no date. Notice the absence of any discussion of an AC from C-suite management since the 74-day letter?

We think an AC is likely here, and that the date will be announced sometime over the next 14 days. There are significant questions surrounding the interpretability of the data.

Also, regarding the increase in allowance on labels to 5 g/d, this is a setback for Amarin, as 4 g/d is indicated for hypertriglyceridemia, and now the labels of OTC high purity omega-3s can creatively state 4 g/d in its directions, matching dosage rec of prescription OM3.