Clinical endpoints used
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- Page 1: We question the efficacy endpoint shown in KM graph. Please see below: a) "Superior PFS" shown in the graph title is not supported by the clinical study design and endpoints. Please revise to ensure the above and also specify the comparator. b). Layout does not mirror copy deck. c). We question the call-out in the KM curve as does not specify endpoints presented are the median PFS. d). Please remove the copy "improvement" as it is unsubstantiated by the clinical study referenced. e). Please add n-values. f). The p-value cited in the copy and layout are incorrect as per the TMA. g). In the layout, the KM curve does not match the copy deck and TMA and is misleading. h). Please ensure graph labels are positioned correctly (s.4.1).
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have to be listed in the past tense, and not listed as instantaneous
comparators have to be specific and not overly broad
Graphs: can differentiate medians - not statistically revelant
Claims made must be based on data that has been statistically analyzed
All graphs must contain a claim of adapted from....