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Alias Born 10/07/2013

Re: None

Friday, 05/09/2014 8:23:43 AM

Friday, May 09, 2014 8:23:43 AM

Post# of 427499
"We appealed to the next level within the FDA and were informed in late April 2014 that that level determined to uphold the rescission determination. Our plan is to appeal the rescission decision to the next level within the FDA in accordance with FDA dispute resolution guidance. ... Based on our communications with the FDA, we currently expect that final positive results from the REDUCE-IT outcomes study will be required for label expansion for Vascepa." - so it is at Woodcock now.
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