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Re: jessellivermore post# 58035

Monday, 08/31/2015 4:02:29 PM

Monday, August 31, 2015 4:02:29 PM

Post# of 428673
The only thing the FDA has to offer is a label change. If you have another suggestion, I'm all ears.

How about not requiring AMRN to get FDA approval for an future off-label promotional statements? Although I can't see how the FDA would agree to that, they would lose all control over AMRN - untenable position for them IMO. This is the only thing I can think of that's a real reason for the delay - talks of looking at R-IT data, getting ANCHOR label, SPA reinstated, etc., are all off base IMO.


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