>>just curious as to why the Atryn data being used for European approval isn't also sufficient for a filing in the US?<<
gfp: The U.S. data set will include the 14 patients from the European application, but the FDA insisted on a trial with a control arm. After considerable negotiation, a compromise was reached to use a control arm consisting of “prospective historical” controls as explained in #msg-5609005. Regards, Dew
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