Zuize, call me crazy, but usually the FDA would want the completion of the enrollment before making a decision on approval We're referring to "Accelerated Approval", which does not require completing clinical trials. Below is the text on Accelerated Approval: ... Drugs with accelerated approval can initially be tested in clinical trials that use a surrogate endpoint, or something that is thought to predict clinical benefit. Surrogate endpoints typically require less time, and in the case of a cancer patient, it is much faster to measure a reduction in tumor size, for example, than overall patient survival. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials ...