Posted by Michael Wonder on 03 Aug 2021
Complete response letter received from FDA for treosulfan
3 August 2021 - Medexus Pharmaceuticals and medac announced today that medac has received a complete response letter from the FDA in response to its new drug application for treosulfan.
The letter stated the FDA had determined that it cannot approve the new drug application in its present form and has provided recommendations specific to additional clinical/statistical data and analyses pertaining to the primary and secondary outcomes of the completed pivotal Phase 3 trial.
