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jessellivermore

08/14/19 1:52 PM

#208817 RE: NickHous #208813

Nick...

Amarin has ICER, RWE, the R-I trial, AHA and ADA all on our side.Vascepa is a very safe very effective drug at lowering risk of CVD events including Death from CVD and is cost effective so it lowers the run-way cost of health care..Why should FDA be dragging their heels when it comes to be getting this drug on the market...If this does not meet the standard for Arbitrary and Capricious behavior on the part of FDA then what possibly could...

There are lives in the balance..Patients who can not wait for whatever is delaying FDA...Something they have not bothered explaining...Why put this drug on a priority review if there is no priority..Or is FDA's definition of priority just Arbitrary and Capricious...I can not think or even imagine a drug which should be ahead of Vascepa on the line to get it into the clinics...

Perhaps Chris Sipes (Covington) can explain that to FDA...

Markipeach

08/14/19 3:29 PM

#208873 RE: NickHous #208813

I have to agree. I think there will be a label expansion in Sept and the ADCOM will be about further expansion in Dec. That would make for a Merrier Christmas