Vion Pharmaceuticals, Inc.
Vion Pharmaceuticals Announces FDA Conclusion
Published in Food and Drug Law Weekly, January 15th, 2010
VION PHARMACEUTICALS, INC. (BULLETIN BOARD: VION) , announced that the U.S. Food and Drug Administration ("FDA") had responded to its Special Protocol Assessment ("SPA") request to evaluate the Phase III randomized trial HOVON AML 92 sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology ("HOVON") of its lead product Onrigin™. The FDA raised concerns with the HOVON trial design as submitted regarding the primary endpoint and study regimen. The modifications requested by the FDA would require a new Phase III trial at significant additional time and expense.
Vion will evaluate whether to file another SPA for an alternative randomized Phase III...
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