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VuBru

10/24/20 10:53 AM

#322117 RE: sentiment_stocks #322074

Senti - FWIW, I agree with your take on the analysis as a likely scenario, and on the FDA support for their new approach. In the original SAP, they called PFS primary and OS secondary, but since I got in in 2017, they always seemed to treat them almost as co-primaries, and the split alpha made sense in that context. In the new SAP, I assume they will keep testing sequentially down the list of secondaries until they hit one that is not p<.05. At that point, anything below that which meets p<.05 would be considered an exploratory endpoint - suggestive of something going on but not definitive.