DENDREON CORP (DNDN) 28.01 -$0.04 (-0.14%) 06:22PM (15 mins delay)

Dendreon's Provenge Looks Likely to Be Approved in Mid-2010

Nov 03, 2009 - 8:48 AM EST

VFC submits:

Shares of Dendreon (DNDN) traded as much as five percent higher on Monday morning after the company announced that it has re-submitted its application for the regulatory approval of Provenge, a therapeutic prostate cancer vaccine that was called 'approvable' by the FDA in 2007. According to the press release, the company expects to hear an answer from the FDA at some point in mid-2010.

In 2007 the FDA - after deciding to wait until the ongoing IMPACT trial was completed before reconsidering the approval decision - indicated that they would approve Provenge if certain survivability points were realized; and those points were met in the Phase III trial, so things look good for the chances of a Provenge approval.

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Source: Seeking Alpha (Nov 03, 2009 - 8:48 AM EST)