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Guilford’s Gliadel Wafer

This article was originally published in The Gray Sheet

Executive Summary

Recent Phase III long-term survival results for the Gliadel Wafer should reverse a non-approvable decision by FDA on a supplemental new drug application, Guilford claims. A March 2002 non-approvable letter from CMS stated the 23% reduction in risk of death with the primary brain cancer treatment was not statistically significant (1"The Gray Sheet" March 25, 2002, p. 12). Recent results show the device reduces the risk of death by 27% over three to four years...

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