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HDGabor

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HDGabor

Re: ziploc_1 post# 53013

Saturday, 07/04/2015 7:00:11 AM

Saturday, July 04, 2015 7:00:11 AM

Post# of 424038
z-

rules established in the SPA

What are these rules?

"In response to two other questions posed by Amarin with regard to hypothetical ANCHOR study results and their adequacy to support approval and/or labeling statements for Vascepa for the proposed indication, DMEP stated, “This is a review issue.” DMEP acted correctly in limiting its agreement under the ANCHOR SPA to issues related to “the design and size [ ] of clinical trials" - APPEAL DENIED by OND / John Jenkins (Sep 11, 2014)
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