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News Breaks
February 25, 2013
08:25 EDTDVAX, DVAXDynavax to host conference call
Conference call to discuss FDA complete response letter on HEPLISAV biologic license application will be held on February 25 at 9 am. Webcast Link
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April 15, 2014
06:08 EDTDVAXDynavax initiates Phase 3 study of HEPLISAV-B
Dynavax Technologies announced initiation of a new phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. This large safety and immunogenicity study, known as HBV-23, was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the FDA in February, 2013. HBV-23 will provide greater clarity regarding the safety profile of HEPLISAV-B by significantly expanding the overall database of vaccinated subjects. The study will also assess the immunogenicity of HEPLISAV-B in subjects for whom approved hepatitis B vaccines are less effective. Dynavax expects that all study subjects will be enrolled by the end of 2014 and all follow-up will be completed by 4Q15.

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