The right to try authority is used to provide access to drugs that are pending approval or specifically unapproved (safety) for people as a last resort for treatment. Vascepa is already on the market for multiple labels. Doctors can off label Rx V and gV to anyone for anything they want today. FDA cant stop that practice unless a clear safety issue occurs due to the drug itself. Seems highly doubtful to me FDA would use that authority as a loophole to grant Amarin exclusive access to an expanded label since the molecule is also available generic and people can readily get it. Ultimately the FDA will do nothing until Amarin or someone else actually tried to file for the label anyway.
News 
Market Data 
Discover 
AI
