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Replies to #32062 on Biotech Values
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DewDiligence

07/30/06 5:14 PM

#32063 RE: walldiver #32062

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.