whether fast track is worth anything or not, has the fda ever granted it to a drug which they don't believe has shown efficacy in earlier trials? can anyone answer that question rather than one i didn't ask? Back in the day, the FDA granted fast track status to MLN's FLT3 inhibitor, MLN518, based solely on preclinical data. You can find the link www.prnewswire.com/news-releases/fda-grants-millenniums-mln341-and-mln518-fast-track-status-77766217.html here . So yes, the FDA has granted Fast Track to a drug that has not shown efficacy in earlier trials.