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Follow-up Discussion on GSK’s October Meeting Minutes, November 19, 2010 - MenHibrix


STN: 125363/0
Date: November 19, 2010
From: David C. Staten, Jr, MPH, CDR, USPHS
Subject: Follow-up discussion on GSK’s October meeting minutes and CR issues related to the free polysaccharide content
Summary: FDA clarified that the current data regarding the free polysaccharide content is not sufficient to address the CR comments. FDA requested additional data on the failed assays. FDA suggested that these data be submitted in advance of receiving the sponsor’s CR response. FDA suggested that the data be submitted to the sponsor’s IND and agreed to review the data in 60 days.