Business Update

Company files response to EMEA list of outstanding issues

Published in Hematology Week, August 1st, 2005

GTC Biotherapeutics, Inc. (GTC) (GTCB) has filed its response to the European Medicines Agency's (EMEA) list of outstanding issues generated during review of GTC's market authorization application (MAA) for ATryn, its recombinant form of human antithrombin.

GTC estimates the EMEA will make a determination on the MAA before the end of October.

"With the filing of our response, we look forward to continuing to work with the EMEA to bring our submission to a positive conclusion," noted Geoffrey F. Cox, PhD, GTC's chairman and CEO. "Approval will be a major milestone in the transition of GTC into a commercial products company."

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Source: Hematology Week (2005-08-01)

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