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Replies to #94331 on Biotech Values
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DewDiligence

04/17/10 3:23 PM

#94332 RE: turtlepower #94331

it seems that ANDS is combining the number of patients on placebo and I'm a bit confused as to whether they are supposed to do that.

They are not doing anything untoward or unorthodox. All 30 patients who received placebo (i.e. SoC) were intended to be compared to the 30 patients in each ANA598 dosing arm. The trial protocol makes no distinction between the 15 placebo patients who enrolled during the 200mg testing and the 15 placebo patients who enrolled during the 400mg testing.

The above is no different from the design of the IDX184 phase-2a trial. In the table in #msg-49003061, half of the 8 control-arm patients were enrolled during testing of the 50mg qD dose and half of the 8 control-arm patients were enrolled during testing of the 100mg qd/50mg BID doses.