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Dynavax Technologies (DVAX) -33% premarket after the FDA rejects its hepatitis B vaccine...

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.
Comments (2)
  • STDvooh
    , contributor
    Comments (641) | Send Message
     
    If the FDA needed more safety data for adults, then why didn't they ask for it, the last time they rejected Heplisav? DVAX needs to ask for a review of FDA procedures in court.
    25 Feb 2013, 11:24 AM Reply Like
  • babajee
    , contributor
    Comment (1) | Send Message
     
    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.
    28 Feb 2013, 07:22 AM Reply Like
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