Randomized withdrawal design had been used in many therapeutic areas (psychiatry, pain, ..) as a mean to enrich the population, reduce the placebo response… However, because of the nature of its design, Randomized Withdrawal studies should be interpreted cautiously as it could not be easily generalized. In this roundtable luncheon, we will discuss and share experiences in summarizing efficacy and safety results from Randomized Withdrawal Studies and challenges that one faces in using randomized withdrawal studies in a filing for a new indication.