Amarin Corp Plc (AMRN)

[heysfguy]

In the upcoming meeting, AMRN and FDA have been tasked with hashing out the very same issues FDA has been asked to resolve previously: what will FDA accept as truthful, non-misleading information that can be shared with the medical community for potential off-label use?

FDA was dragging its feet on this issue forever, and most recently was touting some "public input" meeting sometime in the future. But now, due to the 1st Amendment case, they cannot rely on bureaucratic machinations to drag their feet on this issue any more.

What AMRN will NOT be interested in negotiating is a process for vetting their communications, one by one. Instead, it will be negotiating with FDA to get an honest terms of what the FDA is comfortable accepting in terms of promotional speech. If FDA cannot adequately answer this question, it will be left to adjudication. And currently, the judge is highly unlikely to give the FDA the kind of leeway they've enjoyed in the past.

There's no way AMRN will be running every new promotional communication by the FDA first - that just solidifies the agencies ability to stall, deny, threaten and intimidate.

My guess is the FDA will not be able to come up with acceptable terms, and it will be back in the judge's lap.