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Re: io_io post# 573

Wednesday, 07/18/2007 6:50:17 PM

Wednesday, July 18, 2007 6:50:17 PM

Post# of 9772
"Also the conclusion that the FDA suggested a prophylaxis trial - this was already DOR's intent, and they said so."


that is about the only accurate part of the minutes. The question is how does the drug get approved for acute gvhd if they run trials for prophysaxis

It looks to me like they should get approval for acute under the condition that they run a prophylaxis study
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