>>Why is one data-mining (PPHM) and one not so(BMY)??
Both biomarkers were indeed pre-defined. But for PPHM, they pulled a range out after seeing the results - their range was not pre-defined.
In the BMY case too, the biomarker was directly linked to the activity of their drug, so there is a sound scientific reason for low expression being different from moderate or high. Once you start claiming moderate (but not low or high) is what you need for efficacy, eyebrows are going to be raised.
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