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williamssc

06/19/17 3:44 PM

#186438 RE: Scottwny #186437

Look at it as a whole. 46% as a group had the reduction.

thefamilyman

06/19/17 4:15 PM

#186441 RE: Scottwny #186437

"...doesn't make sense..."? I don't understand. 13 of 28 people is 46.43%. Does that make more sense to you?

"Weren't there 28 people in the 200mg arm? So 46% of 28 people is 12.88 people, which doesn't make sense." - Scottwny

BonelessCat

06/19/17 5:00 PM

#186450 RE: Scottwny #186437

It was a proof of concept trial, not statistically powered. 13 of 28 is 46.42%, rounded down to 46%. Or, ~46%. Working the other way, 46% of 28 is 12.88, rounded up to 13 patients. PoC trials demonstrate trend and are not intended to present more precise results as those for 10 times the patients at a single optimized dose.

Blues44

06/19/17 5:07 PM

#186453 RE: Scottwny #186437

Reviewing the ClinicalTrials.gov website regarding the Primary Efficacy Endpoint of the Prurisol Phase 2 trial it states, "The primary efficacy endpoint will be the percentage of subjects with (greater than or equal to) 2 point improvement in IGA rating as defined by visual inspections of patient lesions. Time frame: 84 days. This is the percentage of all subjects pooled together vs. placebo.