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DewDiligence

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Re: mcbio post# 136332

Friday, 04/27/2012 9:19:37 AM

Friday, April 27, 2012 9:19:37 AM

Post# of 253290
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.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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