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KCSVEN

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KCSVEN

Re: Shinook99 post# 233430

Friday, 12/13/2019 4:26:23 PM

Friday, December 13, 2019 4:26:23 PM

Post# of 426269
Based on the info we have, FDA ordered the halt due to leak of label and expanded approval. Amarin has nothing to PR until FDA actually completes paperwork on label expansion and sends to them. I'm tending to believe that's the most likely scenario. Why would Amarin agree to BO on label, once they get label they have leverage. If they were doing that it just would have been done with CVR's.
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