She said the licensing application for the drug would be submitted in the fourth quarter. She did not know how quickly a decision would be made.
“The FDA determines that timeline,” she said.
Dendreon said in a release it will have more details on the deal during an upcoming meeting with analysts in New York City.
On its Web site, Dendreon says its mission is “engineering and cell processing to produce Active Cellular Immunotherapy (ACI) product candidates designed to stimulate an immune response. ACI holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.”
If approved, Provenge will be launched from Dendreon’s facility in Morris Plains, N.J., with manufacturing capacity supported by its Union City plant and one in California.