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FDA questions will remain an overhang on Dynavax - JPM

  • Late Friday, the FDA cancelled its scheduled committee meeting to review the BLA for Heplisav.
  • JPM says it spoke to management, and heard the following:
  • DVAX expects to have outstanding questions from the FDA in the next several weeks. It did not speculate on the nature of the questions.
  • "In our view, the nature of the questions will remain an overhang on DVAX shares."
  • More of JPM's client note here.
  • Currently DVAX is changing hands premarket at $12.51, 15% above its Friday close when it dropped 31.5%.

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