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BRIEF-Dynavax Technologies received anticipated requests for information from FDA review team in connection with pending BLA for HEPLISAV-B
2016年10月3日 / 上午10点52分 / 1 年前

BRIEF-Dynavax Technologies received anticipated requests for information from FDA review team in connection with pending BLA for HEPLISAV-B

Oct 3 (Reuters) - Dynavax Technologies Corp

* Review team’s questions are in line with company’s expectations

* Working with FDA to resolve remaining questions in order to enable FDA to complete review by scheduled PDUFA action date of Dec 15

* Received anticipated requests for information from FDA review team in connection with pending BLA for HEPLISAV-B

* PDUFA action date of December 15, 2016 remains unchanged Source text: [bit.ly/2cX7rG8] Further company coverage:

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