Dendreon Catches a Break From The FDA

by Jon C. Ogg
24/7 Wall St.


Dendreon (DNDN) is benefitting from something that become thought of as a low probability event: an FDA that buckled at least a little to peer pressure. It has received confirmation that the FDA will accept either "a positive interim or final analysis of survival" from its ongoing IMPACT study to amend the Biologics License Application for PROVENGE as a late-stage prostate cancer treatment. This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.

Mitchell H. Gold, President/CEO: "We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options." So the translation here is that this won't yield an immediate approval, but it could move up the date of an approval considerably.

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