Amarin Corp Plc (AMRN)

[DeepBreath]

goamrn,

Unfortunately for Amarin, high trigs 200-499 was a target population in that reducing trigs was thought to reduce CVE's according to the FDA at some point in time prior to the Adcom, most likely before the SPA agreement was made.

At the adcom, the FDA changed the reason for treating this population from lowering trigs (which Vascepa excels at) to the reduction of CVE's (which at this time cannot be proven until Reduce-it)

Where Amarin got caught up in the crosshairs is with the failed Niacin and Fibrates trials that showed no positive CVE outcome. These are totally different medicines but since they are listed as lipid drugs, the fda has decided to say no to any lipid drug in the 200-500 until it can prove outcomes.

JZ stated in the CC "The FDA has changed their stance base on outcomes files conducted with other drugs. Yet there was no specific or pertinent mention of this change at any point leading up to the AdCom including the sNDA acceptance letter for ANCHOR also known as the Day 74 letter or in any of the various communications and interactions between Amarin and the FDA over the last year, even though the majority of this outcomes data was available for some time.

Those other outcomes trials involve different classes of drugs in patients with lower or normal triglyceride levels, holding Amarin accountable for results of other agents studies in the wrong patient group. None of those outcome studies prospectively enrolled patients who had elevated triglycerides in spite of statin control with LDL cholesterol. This is exactly the type of thing the FDA historically frowned upon, trying to compare totally different agents or classes of agents across groups or drugs.

This is where the fight begins....