Robert J Temple1, Robert T O'Neill2, Carl C Peck3,4. 1. Deputy Director for Clinical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. 2. Former Director of the Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Bethany, Delaward, USA. 3. Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, San Francisco, California, USA. 4. NDA Partners, LLC, Rochelle, Virginia, USA.