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Re: mcbio post# 94265

Saturday, 04/17/2010 10:31:33 AM

Saturday, April 17, 2010 10:31:33 AM

Post# of 257257
ANDS - Base on the initial trial design, the 30 patients receiving placebo were divided into two groups of 15 at 200 mg and 400 mg. The EASL results PR states "Approximately 90 patients have been enrolled in this
study – with approximately 30 patients receiving ANA598 plus SOC at each dose level and 30
patients receiving placebo plus SOC
" while the PR when the patients were dosed last year stated "Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen
receiving placebo at each dose level.
"

I don't recall a change in the trial design since the original PR so it appears that they've conveniently changed how they are going to calculate placebo response to mask the unusually high placebo response.

It seems to me that the results for each dose level should compare 30 patients on the drug vs 15 on placebo and not the entire 30 on placebo or am i nitpicking.

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