It helps that BPAX has an SPA, but we don’t know exactly what statistical thresholds and analyses are in the SPA. Moreover, the recent change in the size of the LibiGel safety trial warrants an extra dose of caution insofar as it might mean an undisclosed change was made to the thresholds and analyses for this trial to be deemed a success. SPA’s and post-hoc design changes go together like and oil and water.
I must have BP on the brain to have said that :- )
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