Amarin Corp Plc (AMRN)

[DeepBreath]

It's a long shot, but I sent my FDA email (touched up a little) to the USA today letter to the editor.

Open Letter to the FDA,
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for an expanded label. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science, I find it hard to believe that different standards are being held for different companies.


Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation", it seems logical that other drugs with the same efficacy should be treated the same. Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers.


I'm trying to comprehend the FDA's inconsistencies with regards to these different drugs. According to the standards that Director Coleman is stating, Amarin's Vascepa, while already involved in a long term outcomes study, should be approved for the Anchor indication.

Please try to help me understand why an effective drug like Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies. I impatiently await your response