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Biotech / Medical : Regeneron Pharmaceuticals
REGN 780.19-0.6%Nov 28 9:30 AM EST

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To: Biotech Jim who wrote (1674)11/10/2014 11:50:32 AM
From: Miljenko Zuanic  Read Replies (1) of 3559
 
This morning we have good news, AMGN-NDA accepted for review by FDA, for the short term “surrogate” indication, without(?) or with “minimal" medical claim. Now, I believe that FDA staff has in advance results from IMPROVE-IT, and that results are: “good trend toward medical benefit”! This leave REGN with chance to file NDA with “partial medical claim”, because by 2015-mid-year they will have advance “post-hock” outcome results from 18(24) months-safety study.

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