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Article: Dendreon Submits Provenge Clinical Data In Rolling BLA.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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West Coast Editor
With the chemistry, manufacturing and controls (CMC) part of its rolling biologics license application for Provenge still to come, Dendreon Corp. submitted the clinical and nonclinical sections to the FDA.
"I wouldn't say one part is harder than the other," said Mitchell Gold, president and CEO of Seattle-based Dendreon, adding that the clinical piece "always gets a lot of scrutiny."
Mark Monane, analyst with Needham & Co. in New York, was cautiously optimistic about the next steps for the prostate cancer drug.
"CMC sections are never in the bag," he said. "They're the most challenging for biotech to do." But the ...