PFS Data
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Figure 1. KM Curve
- Per Provision 1 of the Guidance Document for Claims Based on Kaplan Meier Analysis, inclusion of the median time-to-event as a claim of benefit is only permissible in conjunction with the corresponding KM curve, and data (i.e., hazard ratio and p-value). Please ensure that the corresponding data is presented in close proximity to the headline.
a) Please revise the headline to "ArradiCAN demonstrated a superior reduction in risk of progression or death vs. chemotherapy" or similar as the current copy "Superior PFS compared with chemotherapy: 50% reduction in risk of progression or death vs. chemotherapy" is unsubstantiated and unclear. Furthermore, please remove "50% reduction" altogether, or direct our eyes to support for this data (s. 4.2.3).
b) Please revise the copy "Statistically significant improvement of 9.8 months vs. 6.5 months" to align to Provision 3 of the Guidance Document for Claims Based on Kaplan Meier Analysis, or provide the confidence interval or p-value specific for that particular inter-group difference. As previously noted in 1., please remove the HR and CI data from this callout.
c) Please remove or direct our eyes to support for the "3.3 months" callout. (s. 4.2.3)
d) Please ensure that the figure is disclosed with "Adapted from the Product Monograph" or similar.