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FDA Asks For ODAC’s Advice On Composite PFS Endpoint for GPC’s Satraplatin

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is seeking the Oncologic Drugs Advisory Committee's opinion on using a composite progression-free survival endpoint as the basis for GPC Biotech's application for Orplatna (satraplatin) to treat androgen-independent prostate cancer in men who failed prior chemotherapy once
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