Amarin Corp Plc (AMRN)

[sts66]

"So, what do academics and physicians, payers and patients know about off-label communications that the FDA does not?

You left out the answer to that rhetorical question - something I've claimed before - that FDA guidelines are intentionally vague so they can interpret them however it suits their mood on any given occasion:

In a word, the answer is clarity. Alas, regulators love ambiguity because it gives them unlimited options. And nowhere is this more evident than when it comes to issues concerning communication. It would be generous to call the FDA’s views on the dissemination of off-label information ad hoc.