Amarin will ask FDA about a Priority Review (PR) after submitting the sNDA application...FDA and Amarin will then have several meetings and correspondence and most likely the issue will be decided before 60 days pass from the time Amarin approached them...
Vascepa could only be denied the PR based on non clinical issues...Clinically it meets every requirement...
So the company must stay on the straight and narrow...The information given at JPM would indicate that Amarin could meet the increased demand resulting from the label expansion...I know this sounds bogus..but FDA makes a very big deal about it.
Just the announcement that FDA is granting a PR is going to blast this stock into the cosmos...This is less than five months away...
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