>even if there are multiple 'outliers' with a marked increase in PFS or OS who all seem to come from the Squamous group and this is statistically significant for that subgroup, that data is not sufficient for the narrower label of Squamous approval if the summed trial data for NSCLC does not meet 'statsig?'<
Unless there is something explicit in the Special Protocol Assessment to allow for a squamous-only label, I don't think this can be achieved if the overall trial fails. Regards, Dew
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