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  • Dynavax Technologies (DVAX) -33% premarket after the FDA rejects its hepatitis B vaccine Heplisav, citing the need for additional safety data in healthy adults. DVAX says it's confident it can meet the request for more information, but it may also fast-track a refiling by first seeking approval for sick patients. [View news story]
    Not a good business strategy for DVAX to go to court.
    Remember, in addition to the more safety data for adults, FDA also has asked to supervise additional data from DVAX's process validation program and to clarify information on DVAX's manufacturing controls and facilities related to the assurance of the quality of the commercial product.
    Feb 28, 2013. 07:22 AM | Likes Like |Link to Comment
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