Amarin Corp Plc (AMRN)

[redlyon]

After looking over the PDUFA VI provisions and the latest PDUFA Annual Financial Report (FY 2017), I conclude Dr Woodcock could legally keep user fee work going if she (or Gottlieb, HHS, or whoever up the chain) wanted to exercise a bit of administrative discretion. For sure she can't cash AMRN's user fee check arriving in February (we hope) if the shutdown's still on, but FDA has loads of carryover user fee money. At least $300mil has carried over in each of the last 4 years. Moreover PDUFA VI provided for FDA to set fees so as to always have up to 14 weeks of operating reserves, and additionally to keep a $5mil reserve for potential refunds. These funds unincumbered by the shutdown could easily cope with finishing priority applications within 30 or 60 days of their action date and reviewing new applications up to the point of accepting them for filing. Not only could this be done, but the FDA employees could be paid with this already appropriated user fee money. Come on, Janet, think outside that tiny FDA box you're in!