Amarin Corp Plc (AMRN)

[HDGabor]

BB,

'enactment of this Act' is the date when the Bill passed and signed and not the date of Committee's report, however I think it's not the most important part of the report since it 'just' about report to Committees

I think the important parts are:

'fundamental questions concerning FDA’s adherence to the statutory and regulatory guidelines that apply to the SPA process as well as to questions concerning fairness to the sponsors. The Committee would like to reiterate that FDA is expected to adhere to the established standard as informed by the Congressional Record and the 1997 PDUFA Goals Letter' and

'The Committee also expects that, as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.'

Basically the Committees said:
- FDA did not follow guidlines and policy
- did not notify the sponsor in time