Published in Hematology Week, August 1st, 2005
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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