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doingmybest

01/26/17 10:48 AM

#98341 RE: Doktornolittle #98261

All of the data has to be deeply understood. The company is responsible for the info when it is presented to the FDA. You cannot afford to have FDA ask many questions and then have to go back into research mode. Time has to be invested to understand the data, reach logical conclusions, strategize the approach to data utilization and anticipate all possible agency questions. There is much to do by the company post study conclusion, much of it has to occur even before topline data is published. Some of the in-blinded data may be available and being worked on earlier.