I think I see what App is saying.
According to clinicaltrials.gov:
Primary Outcome Measures:
Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]
The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered.
So, the primary outcome is defined by meeting a standard (lesion area has decreased by =20%) and not in comparison to any other drugs. In fact, for all outcomes, there is no comparison to Dapto or any other drug.
But, in the submission to the FDA the comparison becomes important in presenting non-inferiority or superiority over the current standard treatment.
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