BioCentury
ARTICLE | Regulation

Completely confusing

May 10, 2004 7:00 AM UTC

Genasense Lessons

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...