heysguy...
Good post...
I don't have any strong opinions on why Amarin has not broadcast the EPA/AA ratios...I do not think its an FDA thing...My opinion is the FDA is not concerned about how Vascepa lowers CVD event risk..All the FDA wants to know is how much does V lower the risk. And what are the
safety concerns..
When FDA reneged on the ANCHOR SPA...The FDA message was clear...We need to see a CVOT..I get that and after a couple of years of wanting to go kick some FDA ass; I realized their decision was the right one..Now we (Amarin and the FDA) have the event reductions..the safety information..All is good (great) and it is time to move on. I do not see any reason why FDA should not grant a Priority Review base on the R-I results and the fact V treats a "serious" medical condition (ischemic CVD) and is a life saving drug..
No I am more concerned that Amarin and its doctors do not understand, or can not explain, how changes in the EPA/AA ratio lead to lower CVD event risk...They are not fluid in their understanding of how EPA works on a cellular level...The fact that they and their doctors are all wrapped up in side issues like cholesterol domains (these are more important in cancer research as effect the transfection of nucleotides)....
My point is that Vascepa is an Omega-3 (n-3) and Amarin and its doctors should be experts on the physiology and pathophysiology of n-3s and ..They are not..Its one thing to have a drug that works as well as Vascepa..but it is embarrassing when you don't understand how it works.
Particularly when there is very complete information on how EPA works..(EPA was working in 500 mil years BC..in the very first multi cellular animals (primative sponges).
IMO... Amarin Would be in a much stronger position as far as clinicians are concerned if they could explain how Vascepa works..This is the twenty first century...
":>) JL
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