Completely confusing
Genasense Lessons
Completely confusing
Investors and analysts who followed Genta Inc.'s development of Genasense oblimersen closely received a surprise when they downloaded FDA's analysis of the company's NDA on April 30. It was the first hint that an independent review conducted for GNTA had failed to confirm any of the five complete responses (CRs) the company had previously announced.
FDA revealed in its briefing documents, and in a presentation to last week's meeting of the Oncologic Drugs Advisory Committee, that GNTA contracted RadPharm