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Re: DewDiligence post# 168329

Wednesday, 10/16/2013 9:46:40 PM

Wednesday, October 16, 2013 9:46:40 PM

Post# of 257265
Maybe business decision coincides with regulatory decision in this case. IF FDA had strongly suggested they'd like to have HIV co-infection in initial NDA at EOP2, most companies would follow. Many companies I know paid prices for following their own business decisions while disregarding regulatory guidance/decision.

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