Amarin Corp Plc (AMRN)

[HDGabor]

BB,

Respect, but please read and check twice the topic / issue before post (ie.: 07/28 label change). So,

what's the reasoning used?

The same as for rescission. C'mon man: u could not say it's 100% that it will be reinstated now.

Congress has demanded new guidance

Yes, but no. The Congress "directs FDA to report to the Committees ... within 60 days of enactment of this Act regarding the standard by which FDA would rescind a SPA. Lastly, to ensure agreement over the standard to rescind a SPA, the Committee directs [encourages] FDA to revise and re-issue, after public comment, its existing guidance regarding SPA agreements to clarify the agency’s interpretation of the statutory standard regarding SPA agreements and the rescission of such agreements.

they must comply with to receive budget $$$

No budget $$$ linked to this