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Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?
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If so, what content would be acceptable to include in such a table? Would it be strictly non-clinical data (e.g., patients characteristics & inclusion criteria)? I assume efficacy data would not be permissible given that it would be for 2 independent trials rather than a head-to-head RCT.
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If so, what content would be acceptable to include in such a table? Would it be strictly non-clinical data (e.g., patients characteristics & inclusion criteria)? I assume efficacy data would not be permissible given that it would be for 2 independent trials rather than a head-to-head RCT.
