Amarin Corp Plc (AMRN)

[raistthemage]

JT should not have announced it immediately IMHO...

The announcement should have coincided with a lawsuit being filed against the FDA for "arbritrary and capricious" demanding an emergency supression of the adcom and that the court order them to keep the PDUFA date. Furthermore that all things significant in the Reduce-It study would be on the label at the bare minimum.

The FDA obviously needs new laws constraining its behaviour.

1. All its sovereign immunity needs to go away, every FDA action should be challengable in court. Its too opaque, incompetent and corrupt to deserve any "deference". At the very least broken SPA agreement should be immediately challengable in court without going through FDA appeals. Yes this would render the FDA mostly a paper tiger but that is exactly the point.

2. It has too much incentive to deny drugs and not enough to approve them. FDA employees need to become civilly and criminally liable for not approving drugs or even delaying them if they later turn out to have acted wrongly.