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Hawk_Driver

08/11/15 12:19 PM

#56143 RE: Dancing in the dark #56140

As I understand it, Amarin might be risking legal exposure by communicating this study, since it isn't one of the 13 reprints the court specifically declared truthful and non-misleading by the Court.

"The Court therefore holds, and the FDA does not dispute, that Amarin’s dissemination of these
reprints, under the circumstances proposed, would be neither false nor misleading."

That said, the chance of FDA proving such a communication untruthful(0%) or misleading(<1%) is so low it's worth the risk