Biotech Values

[DewDiligence]

DVAX is off 41% in AH trading on the FDA decision that Heplisav, a vaccine for HBV, is unsuitable for use by the general public. The FDA says the only potential indication for Heplisav is for patients with renal failure, and pursuing this diminished indication will require more clinical studies.

Despite having met its primary endpoint in a phase-3 trial, Heplisav has been on FDA clinical hold since March due to a case of Wegener's granulomatosis (#msg-27721992).

http://biz.yahoo.com/bw/081021/20081021006644.html

DVAX is in a very bad way inasmuch as Heplisav is all the company has left, following the discontinuation of Tolumba in May (#msg-29364787).