"What we found is that Fast Track designation is no augury of clinical or regulatory success (we'll outline our data set in the tables below and also provide you with a link to the underlying spreadsheet). In fact, it correlates with products addressing relatively gnarly diseases and appears to be associated with a higher-than-average failure rate in late-stage clinical trials. That can come as a shock to investors and patients who view the designation as a tacit FDA endorsement. Even industry insiders regularly mix up Fast Track designation with Priority Review and Accelerated Approval."
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