Will Dynavax’ HBV Vaccine Resubmission Make The Safety Grade?
This article was originally published in The Pink Sheet Daily
Company says it now has enough safety data to support a new FDA filing in the first quarter of 2016, and that it expects a superiority claim for diabetics.
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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.
After clinical hold, lost partnership and rejection by an advisory committee four years ago, Dynavax will again make its case for approval of Heplisav-B.