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Tuesday, September 01, 2015 8:18:16 AM
From a practical perspective, all that's missing is insurance coverage - so how can Amarin get insurance coverage? We all know the answer to that
What would the FDA get? We all know that answer as well
So what we don't know is all the permeations of settlement possibilities - all of which are "additive" to both parties - otherwise there would be no settlement talks
I will go out on a limb and suggest your personal history of litigation in the construction industry is likely not an appropriate yardstick to predict a settlement outcome in this case. And while I would agree that willingness to settle (in your context) would be seen as a sign of weakness that is NOT the case here- Amarin has been materially harmed and now, for the 1st time, the FDA is now facing it's own harmful consequences of losing. Far different than Amarin's monetary consequences, but consequences nonetheless.
In summary I cant see how any of your hundreds of cases apply here (terrible business model BTW). Your allowing a narrowed personal bias ( win- lose) color the obvious.
Amarin is facing down a regulatory agency with largely unlimited power. They seek not a financial settlement, but a regulatory one. the potential outcomes are not one loses and the other wins. The very fact a settlement discussion is occurring is because of the possibility of a win- win - not a win- lose.
This 1A move is more like "MAD" policy during the cold war - we took a direct hit at the ADCOM but we finally have a few nukes of our own ready to launch..
Mutual Assured Destruction - come and get it FDA, our finger is on the button- or we can elect to live and let live ....
Think man
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