Dynavax Technologies
Corporation DVAX today announced that the U.S. Food and
Drug Administration (FDA) has informed the Company that its Vaccines
and Related Biological Products Advisory Committee (VRBPAC) is
scheduled to discuss HEPLISAV at its meeting on November 14-15, 2012.
Dynavax's Biologic License Application (BLA) for HEPLISAV, pursuing
an indication for immunization against infection caused by all known
subtypes of hepatitis B virus in adults 18 through 70 years of age,
is currently under review by the FDA. The Prescription Drug User Fee
Act (PDUFA) date for the FDA to complete its review is February 24,
2013.
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