Executive Summary

Firm met with FDA Commissioner Young and senior FDA staff July 20 to discuss the design of proposed further clinical trials for its AIDS therapeutic Imreg-1 and "when and under what circumstances during the second controlled trial of the drug, a treatment protocol might be initiated," the firm said Aug. 29. An FDA advisory committee concluded in April that the biologic's effect on ARC must be corroborated by further testing ("The Pink Sheet" April 10, T&G-1). Imreg-1's Treatment IND application for ARC patients was denied by the agency April 28 ("The Pink Sheet" May 15, T&G-12).