Could get fast tracked, orphan drug status, on really good data. Has happened before.." I think you might have the wrong end of the stick on this; “fast-tracking” an application depends on its results in Phase III trials. They need not reach the full intended trial endpoint, but trials have to be substantially underway before an application is made, and have to have shown substantial benefit with good safety at what are called “surrogate endpoints” and “intermediate clinical endpoints” where it is possible to derive what the longer clinical endpoints will be. An example of this was the “fast track” of the approval for the HPV vaccine; since it is known that almost all cervical cancers are caused by HPV infection, an intermediate clinical endpoint that demonstrated an overwhelming protection against the most common cancer-causing strains of HPV over a period of a couple of years, with a good safety profile, meant that there was good cause to believe it would have a longer beneficial impact on infection incidence and cancer rates. Essentially, it had *already* been successful in Phase III trials.
The “fast track” speeds up the bureaucracy dealing with the results of trials, but cannot be applied for before there are results. And it is only invoked where there is substantial evidence of a substantially beneficial result with a good safety profile, which counts as a success in trial."
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