BioCentury
ARTICLE | Company News

Dor's orBec not approvable

October 20, 2007 1:45 AM UTC

DORB was off $0.27 (58%) to $0.19 on 13.5 million shares on Friday after receiving a not approvable letter from FDA for an NDA for orBec beclomethasone to treat acute gastrointestinal graft-versus-host disease (GvHD). The company said FDA requested additional clinical trials to demonstrate the safety and efficacy of the oral corticosteroid. DORB plans to request a meeting with FDA to discuss the next steps. ...