STNS Actuality, the fda response is to a stns (Pharming, STNS Dutch counter part) application for a Biologics License, and not a jump through hoops kind of a deal... see below...
>>>>> Pharming lodged its Biologics License Application (BLA) for Rhucin to the FDA in late December and the FDA has 60 days to accept the application, triggering the start of the regulatory approval process -- a process which is likely extend into 2012.