Dynavax Technologies Corp (DVAX)

[Wildbilly]

Dynavax says Heplisav-B PDUFA date of December 15 still a go

Dynvax (NASDAQ:DVAX) issued a statement this morning saying the FDA intends to provide information requests in the coming weeks related to its review of the company's Biologics License Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].The agency indicated that it will review the overall immunogenicity data from the Phase 3 HBV-23 study to support the proposed adult indication but it will not review immunogenicity data related to sub-populations including diabetics because the data were not a direct response to its February 23, 2013 Complete Response Letter (CRL). A Class 2 resubmission, which is what this is, relates only to the issues cited in the CRL. Additional data will need to be submitted as a supplemental BLA following approval. The company says the FDA has communicated that the December 15 PDUFA date should still be achievable.

http://seekingalpha.com/news/3207025-dynavax-says-heplisav-b-pdufa-date-december-15-still-go-shares-16-percent-premarket