Apthera Receives Special Protocol Assessment (SPA) From FDA For Pivotal Phase III Tri
 

Apthera, Inc. announced that it reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the Company's lead drug, NeuVax. The SPA is a written agreement between the trial's sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase III trial to be used in support of a Biologics License Application (BLA).

More...