DOR BioPharma, Inc. has reached agreement with the FDA on the design of a confirmatory Phase III trial for its lead product orBec for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD). The agreement was made under the FDA’s Special Protocol Assessment (SPA) procedure. The SPA is an agreement with the FDA regarding the trial’s design, including endpoints, sample size, control group and statistical analyses. The design has been deemed acceptable to support ...