be very careful, take a look at PRR(for disclosure I have invested in). From phase IIa trials to Phase IIB has been just over 4 years. And they havent even began Phase III yet they are just enrolling. So before the back slapping starts bio's have years to run even if Orphan status is granted.
If you want to see a timeline have a look at PRR. Whilst not in the same theraputic field it certainly shows how long the road is.
Also dont forget the FDA can send companies back to do trials again ala DNDN.
I think the ANP story is a good one but getting to market in 2 years I severely doubt it.
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