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Post# of 253274
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exwannabe

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exwannabe

Re: jq1234 post# 118130

Tuesday, 04/12/2011 11:13:12 PM

Tuesday, April 12, 2011 11:13:12 PM

Post# of 253274
This was not an efficacy halt, and that is the whole problem.

The DSMB can request a halt when EITHER arm is doing bad for safety reasons. That is what happened.

The problem is that the efficacy data is now somewhat in question.

I do agree, this is not an FDA problem (unless one implies they need stronger controls on DSMBs).


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