Amarin Corp Plc (AMRN)

[VuBru]

Raf - Agreed that secondary prevention is a no brainer. If Amarin had applied in their sNDA for that label alone, and had sent in a separate application asking for a primary prevention label, we would have secondary prevention label approved in September without doubt. Probably would have an adcom for the primary prevention issues regardless. I am assuming they sent everything in with one application asking for a single label (never heard otherwise). I also do not think the FDA would display the bureaucratic initiative to separate the labels in house on their own. No inside info, but I think the label issue is as big or bigger driver of the adcom. Rehashing the same MO issues discussed at last adcom just doesn't make sense to me. Nothing has changed.

I agree with TTE's post suggesting that whether statins used in R-It were water or lipid soluble (there likely would be a mix) is an important issue for the company to address. If random assignment worked, they should have a roughly equal mix of different statins across the two study groups, and any negative impact of MO on outcomes would only be expected in whatever % of patients were on lipid soluble statins. They could use this to create scenarios to quantify how much the R-It RRR would have been impacted by MO (my expectation is no more than 5%, which would still leave R-It with results stronger than they anticipated when the trial was designed.