Dynavax (DVAX) VRBPAC Cancellation Implications are More Positive than Negative - Cowen
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Dynavax Provides Regulatory Update on HEPLISAV-B
September 4, 2016 8:20 PM EDTBERKELEY, CA -- (Marketwired) -- 09/04/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016. The Agency informed Dynavax that the VRBPAC meeting was cancelled and... More
