I don't have exact dates to hand but I'm currently invested in a therapeutic which is in the Activ2 US fast track program, has been since early this year and isn't due to report until well into H2.
That is a repurposed inhaled drug based on interferon and is already known to be safe for humans but it is still having to go through the safety testing (which is Phase II, alongside efficacy). The fast track is an enabler, giving money, supporting recruitment of candidates and resources to test locations. I believe they also assist with setting up volume manufacturing and no doubt a whole load of other stuff.
I don't think 5 years or more is unusual for a run-of-the-mill drug. I'm sure I read that the one I mentioned has been being developed for 15 years.
This is one reason why the major pharmas wouldn't really be too keen on the idea which floated recently about making the drugs patent free. They have invested a lot in them and don't want cheap knock-offs to come out as soon as they are on the market.
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