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DewDiligence

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DewDiligence

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Re: gfp927z post# 10476

Friday, 04/29/2005 11:01:39 AM

Friday, April 29, 2005 11:01:39 AM

Post# of 257269
>>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

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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