>True, but in GTOP's case I believe the cumulative p value threshold is much too stringent for this to be the only reason.<
Let’s reduce this discussion to the bare essentials: did the FDA give GTOP a hard time with the pivotal-trial parameters, or did the FDA give GTOP an easy time?
The correct answer is the latter: an easy time.
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To see this another way, pretend you are the executive in charge of designing the pivotal-trial program for company X. The FDA offers you two options for an SPA that assures approval of your drug if it meets the requirements set forth in the SPA; however, you must pre-select which of the two options to incorporate into the SPA:
1) Success in two identical trials with N patients each and a p-value threshold in each trial of 0.05.
2) Success in a single trial with N patients identical in design to the trials in option #1 except that the p-value threshold is 0.01.
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Which option would a reasonable person select?
Option #2, of course.
Anyone who opts for #1 needs to take a refresher course in statistics!
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