My understanding of fast track was that the status increased interactions with the FDA thereby speeding up the clinical trial process and best served a company when the status was granted early in development. And, in most cases, fast-track seems to be a vehicle of small biotechs. However, DNA applied for fast tracks status for Lucentis AFTER phIII trial results had been reported -- DNA stated that it was to allow for rolling submission of data. The FDA denied DNA fast track, but then gave the drug priority review. So, I am a bit confused about the actual advantage for fast track late in development and the FDA's decisions regarding the granting of such. Maybe the FDA is (dare I blasphemy) not consistent.....:->!
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