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BonelessCat

10/26/13 4:32 PM

#44696 RE: govorchin #44688

The expanded cohort follows the one in which they finally see a DLT. If they complete Cohort 7, then in Cohort 8 one or more has an adverse event that establishes a DLT, then the dose at Cohort 7 is repeated for an expanded cohort of 12 subjects to establish the MTD. The 12 subjects are the last cohort of the Phase 1 trial.