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MGI Pharma Saforis “Approvable” Letter Seeks More Data

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is asking the company to conduct an additional Phase III trial to establish efficacy of oral mucositis therapy.

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Saforis Granted Priority Review

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MGI’s Oral Mucositis Therapy Saforis NDA Submitted

The firm had planned to file the application for glutamine in the third quarter of 2005.

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