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DewDiligence

02/12/07 4:16 PM

#2703 RE: valueHunter #2702

>What is the status of ammending the EU approval of ATryn in surgery to include childbirth?<

Data from the phase-3 U.S. trial will be used for the EU label expansion. The application to the EU to expand the label ought to come around the time that GTC submits the BLA to the FDA or perhaps a little sooner.