http://pharmaweblog.com/blog/2007/06/12/rimonabant-ac-mtg/ Pharmaceutical and biotech science and business Fri, 29 Aug 2008 23:16:37 +0000 http://wordpress.org/?v=2.0.2 http://pharmaweblog.com/blog/2007/06/12/rimonabant-ac-mtg/#comment-61 Fri, 15 Jun 2007 18:39:11 +0000 http://pharmaweblog.com/blog/2007/06/12/rimonabant-ac-mtg/#comment-61 [...] In my last post, I  discussed what I believed would be the basis for debate and concern among the panelists at Wednesday’s FDA DMEDP Advisory Committee–the benefit to risk balance of the drug in light of modest efficacy and risk of suicidality.  This was indeed the topic of much of the committee’s deliberations.  As you now know, the committee voted unanimously (14-0) against approval of rimonabant due to a perceived unfavorable benefit to risk balance.  They also voted unanimously that Sanofi-Aventis hadn’t sufficiently characterized the safety profile of the drug. [...] […] In my last post, I  discussed what I believed would be the basis for debate and concern among the panelists at Wednesday’s FDA DMEDP Advisory Committee–the benefit to risk balance of the drug in light of modest efficacy and risk of suicidality.  This was indeed the topic of much of the committee’s deliberations.  As you now know, the committee voted unanimously (14-0) against approval of rimonabant due to a perceived unfavorable benefit to risk balance.  They also voted unanimously that Sanofi-Aventis hadn’t sufficiently characterized the safety profile of the drug. […]

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