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Re: Will_Penny post# 9841

Wednesday, 03/12/2014 11:27:42 AM

Wednesday, March 12, 2014 11:27:42 AM

Post# of 48316
Salegov and Will...both of you guys are correct. The amendment is being made to increase dosing which is why a PIIa is conducted. It's for dosage adjustment and safety measure. This in my opinion is a positive because the TRAE must be low so they are going to capitalize on that by seeing if changing the dosing schedule will provide additional efficacy to patients.

PIIb will have a focus more in efficacy and these modified dosing schedules will still be assessed for safety as well.

GL