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DewDiligence

04/27/12 9:19 AM

#140911 RE: mcbio #136332

DVAX submits Heplisav BLA:

http://finance.yahoo.com/news/dynavax-reports-heplisav-tm-bla-200000168.html

An advisory panel is likely for Heplisav, IMO. The possible 2012 dates for the advisory panel are Jul 18-19, Sep 19-20, and Nov 14-15 (http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm ). The panel could conceivably he held in early 2013 if the FDA is conducting a standard review, which would put the PDUFA date in Mar 2013.