Yesterday, an FDA advisory committee panel voted 16 to 0 to approve an expanded label for Amarin's (AMRN) Vascepa that will make it a multi-billion-dollar blockbuster drug that could potentially outshine the performance of Humira and Lipitor.
As I watched the committee members debating on the target population on my screen, and whether approval should be for primary or secondary prevention, I think I said to myself - "It does not matter; we are through."
Yes, we are through indeed; however, it still does matter whether Vascepa gets approved for the entire patient