Ann: Imugene Enrols First Cohort of PD1-Vaxx Clinical Trial, page-47

Hi Captain, I was referring this to the phase 2 Herr vaxx study. However the way I read this from the FDA is that fast track can happen at anytime of development at the request of the drug developer with a decision made in 60 days. By no means am I an expert would love more insight and whether Imu has made various requests to the FDA. No response back from Imu on this request by email

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.