Will Dynavax’ HBV Vaccine Resubmission Make The Safety Grade?

Company says it now has enough safety data to support a new FDA filing in the first quarter of 2016, and that it expects a superiority claim for diabetics.

Dynavax Technologies Corp. is planning to resubmit its hepatitis B vaccine – Hepislav-B – to FDA at the end of the first quarter after amassing what it thinks are enough safety data to satisfy the concerns in a complete response letter from early 2013.

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