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Post# of 257689
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DewDiligence

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Re: iwfal post# 119836

Wednesday, 05/11/2011 3:26:01 PM

Wednesday, May 11, 2011 3:26:01 PM

Post# of 257689
From a practical standpoint, an SPA for a trial with an adaptive design is almost like not having an SPA at all. The whole point of an SPA is to preempt criticisms that can cause the FDA to reject an application, and an SPA for an adaptive design doesn’t really accomplish this.

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

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