FDA cancellation of an advisory committee meeting can often be viewed as an ominous sign of an application's prospects. However, Dynavax Technologies Corp. suggests a more positive view, saying the agency called off a public review of the adjuvanted hepatitis B vaccine Heplisav-B because the meeting was not necessary for a timely regulatory action.
Heplisav-B Review Still On Track Even After Cancelled Advisory Cmte., Dynavax Says
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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