Onrigin laromustine regulatory update

Vion received a complete response letter from the FDA for an NDA for Onrigin laromustine as a remission induction therapy in patients ages 60 and up with de novo, poor-risk acute myelogenous leukemia (AML). In the letter, the agency recommended that the company conduct an additional randomized trial and addressed clinical pharmacology and manufacturing issues. Vion had previously said that it does not have enough funds for a new randomized study and if it is not successful in completing a sale of assets, restructuring or financing, it will have to curtail or cease operations, liquidate its assets or file for bankruptcy. ...