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Nature Biotechnology 26, 487–489 (1 May 2008) | doi:10.1038/nbt0508-487
The special treatment
Abstract
When Dendreon disclosed in mid-March that the FDA had agreed to an amendment to its special protocol assessment (SPA) related to the firm's phase 3 trial of prostate-cancer vaccine Provenge (sipuleucel-T), Wall Street was pleased. But the news cast an even brighter light on SPAs, which have steadily gained favor since the agency issued its formal guidance announcing them six years ago.
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