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

This article was originally published in The Pink Sheet Daily

09 Oct 2009
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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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FDA Answers sNDA For Spectrum's Fusilev With "Complete Response"

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Executive Summary

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