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Re: TOB post# 74575

Saturday, 10/25/2014 4:17:21 AM

Saturday, October 25, 2014 4:17:21 AM

Post# of 402700
Can I trouble you to explain, please?

Given:
"The primary endpoint was clinical success in the intent-to-treat population, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, when observed 48-72 hours after the first dose of study drug"
"All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint"
"the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin"

If the clinical success (20% reduction in lesion area) at the endpoint of the Brilacidin treatment was measured at 48-72 hours after the first dose (at which point dosing would be at least 2/3 complete if not 1-2 days past completion), how can relative success be compared to the daptomycin regimen which, after 48-72 hours after the first dose, would only be 2/7 or 3/7 complete?

Thanks.

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