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BioPharmaceutical

FDA Answers sNDA For Spectrum's Fusilev With "Complete Response"

This article was originally published in The Pink Sheet Daily

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Executive Summary

If two therapies perform similarly in a head-to-head trial, can a sponsor use the failed superiority data to claim non-inferiority? Spectrum hopes so.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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