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FDA Issued Complete Response Letter To Dynavax Saying SBLA For Four-Dose HEPLISAV-B Regimen Did Not Provide Sufficient Data To Support Full Evaluation Of Effectiveness Or Safety

FDA Issued Complete Response Letter To Dynavax Saying SBLA For Four-Dose HEPLISAV-B Regimen Did Not Provide Sufficient Data To Support Full Evaluation Of Effectiveness Or Safety

美国食品药品管理局向戴纳瓦克斯发布了完整的回复信,称四剂HEPLISAV-B方案的SBLA没有提供足够的数据来支持对有效性或安全性的全面评估
Benzinga ·  05/14 20:35

FDA Issued Complete Response Letter To Dynavax Saying SBLA For Four-Dose HEPLISAV-B Regimen Did Not Provide Sufficient Data To Support Full Evaluation Of Effectiveness Or Safety

美国食品药品管理局向戴纳瓦克斯发布了完整的回复信,称四剂HEPLISAV-B方案的SBLA没有提供足够的数据来支持对有效性或安全性的全面评估

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