Business Update
Bioenvision provides update on Evoltra European regulatory activities
Published in Law and Health Weekly, January 27th, 2007
Bioenvision, Inc., (BIVN) has completed the substantive work and analysis involved with finalizing the Marketing Authorization Application (MAA) to expand the Evoltra (clofarabine) label and is now involved with the administrative aspects of formally submitting the filing to the European Medicines Agency (EMeA) for the use of Evoltra in adult AML patients over 65 years and who are considered unsuitable for intensive therapy.
The formal submission of the MAA is expected in the early part of Q1 2007. Bioenvision continues to expect a decision on this regulatory filing in calendar 2007.
"We are taking the appropriate steps to aggressively, but...
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