Dynavax shares dip after FDA asks for more time to sort out Heplisav post-marketing plan
Just a few days after a lopsided FDA panel in its favor, Dynavax $DVAX has run into an 11th-hour challenge in gaining an FDA approval for its hep B vaccine, Heplisav.
According to the biotech, the FDA has asked for more time to hammer out the details of a post-marketing safety study. Regulators are saying they want to know more about the timelines and specifics on a trial that is intended to clarify concerns about the myocardial infarctions seen in the late-stage studies.
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