With that said, I can't rule out the possibility of a Vascepa win in the Reduce-It study. A successful outcome is a definite possibility.
Is there any chance Amarin sues FDA on the grounds that the agency reneged on the Vascepa Special Protocol Assessment (SPA) agreement?
You've been reading the message boards again, haven't you?
Um...yes.After I told you not to believe anything you read on message boards? I know. I'm sorry, I feel shame. You should! The FDA did not renege on the Vascepa SPA. We've talked Tuesday in our preview of the advisory panel how SPA agreements are fungible. These agreements can change -- or can be ignored entirely -- when facts or the science underlying them change. That is exactly what happened with Vascepa. Okay, but Amarin, on its conference call Wednesday night, said it was reviewing its legal options regarding the Vascepa SPA. Amarin's management team is in desperation mode. They'll say or do anything to keep their jobs. Taking legal action against the FDA is a dead-end move. Amarin has no case. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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