I think the track record speaks for itself - Undermining the FDA by winning the NCE and 1st Amendment Case. Nay sayers will have to wait for the outcomes of the 1A case.
AMRN: what can you offer us so that we don't seek PI?
FDA: nothing, we want to see RI data.
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At this point, I think that AMRN would go to the judge to seek PI. The fact that we are not there yet shows me that something significant is being negotiated.