Replies to post #172194 on Biotech Values

[poorgradstudent]

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 here.

So yes, the FDA has granted Fast Track to a drug that has not shown efficacy in earlier trials.