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PDUFA Cliffhanger: Will FDA End The Provenge Regulatory Saga?

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA approval of Provenge for prostate cancer could come May 1, opening the door for the launch of the first cancer immunotherapy.

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Dendreon Readies For Next Provenge Hurdles: Supply And Reimbursement

Having gotten over the hurdle of FDA approval with the market's first therapeutic cancer vaccine, Dendreon now faces the challenge of getting Provenge to the market. Already the company is also signaling that supply is unlikely to match demand in the near term

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