Heplisav-B Review Still On Track Even After Cancelled Advisory Cmte., Dynavax Says

06 Sep 2016
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

FDA calls off November meeting to give 'more time to review and resolve several outstanding issues' with adjuvanted hepatitis B vaccine; Dynavax says agency determined meeting was not necessary to ensure regulatory decision by Dec. 15 goal date.

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Heplisav-B Review Still On Track Even After Cancelled Advisory Cmte., Dynavax Says

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