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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