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DewDiligence

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Re: walldiver post# 32062

Sunday, 07/30/2006 5:14:29 PM

Sunday, July 30, 2006 5:14:29 PM

Post# of 257392
Did the Tarceva trials you cited have an SPA? If not, then comparing the p-value threshold of those trials to a trial such as GTOP’s that does have an SPA is apples vs oranges.

To obtain near assurance of FDA approval if the specified conditions are met, a sponsor seeking an SPA generally has to agree to more stringent requirements than what might be possible without an SPA.

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

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