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Re: BAR123 post# 163290

Tuesday, 08/21/2018 3:16:35 PM

Tuesday, August 21, 2018 3:16:35 PM

Post# of 464448
Brich, Don't know how they will handle the Aussie arm of the trial but, we may see a "seamless" US trial arm. Take a look at this streamlined approach to approval of Keytruda in lung cancer. Think we will be seeing this "real time" approval method for NDA's in CNS diseases also.

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https://www.fiercepharma.com/pharma/under-fda-pilot-merck-s-keytruda-scores-paramount-approval-lung-cancer?mkt_tok=eyJpIjoiWldaaE5HRTNNR1JqTm1WaCIsInQiOiJxWmpUNE1qWXdOOXErYWJHeTQreDZPTGFpUXZaVFFOcmNobE5UeCtcL1paZTdCWElkZzArdFEwUnFlXC9pajh0TXBNZmJUVko4Mmt0SnFJMzhHVld6ZGtKd2NiOUJBQVk3TWlqMzIzdlNsR0NNdmtoV3lwbFBKUWhNNSs3ZE42bzUwIn0%3D&mrkid=6254940


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