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BioChica

12/22/15 10:40 AM

#67390 RE: bidmark #67389

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.

but in particular because of its well established track record, that anything of substance will result from these extended settlement discussions.

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rafunrafun

12/22/15 11:39 AM

#67395 RE: bidmark #67389

Let's take the worst case scenario...

Both sides began to negotiate over 1A...

AMRN: give us ANCHOR and we will not seek PI.

FDA: no

AMRN: label change?

FDA: no

AMRN: expedited review of RI?

FDA: no

AMRN: XX$ million?

FDA: hell no.

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.