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Genta submits new data to Genasense NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genta's major amendment to its Genasense (oblimersen) NDA for chronic lymphocytic leukemia will extend the user fee goal by 90 days to Jan. 29, Genta said Oct. 30. New analyses "reinforce" the conclusion that Genasense increased durable complete remissions, the company said. Genta is working to counter an FDA advisory committee rejection of Genasense in September due to lack of evidence of clinical benefit...

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