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Thursday, 04/02/2015 8:43:17 PM

Thursday, April 02, 2015 8:43:17 PM

Post# of 426271
Agreements vs. contracts. Are we splitting hairs?

I am not an attorney, but the unilateral cancellation of the SPA by the FDA seems completely counter to the basic legal constructs of both contracts AND agreements.

I think a court would say the government has an extra burden of proof to use the "effectiveness" excuse for cancelling the SPA, and even if they successfully cancel it, AMRN may be due some consideration/remuneration for the tens of millions of dollars and years of effort involved in holding up their part of the agreement.

HD, I know you keep saying that this is within the FDA's rights, as the law currently stands, and I completely agree with you. But let's remember there are plenty of laws and regulations passed by Congress that get tested in a courtroom and are thrown out.

I know AMRN is publicly committed to finishing REDUCE-IT, and keeping their balance sheet together in the interim. But in the meantime, if the FDA isn't considering some sort of compromise on allowing expanded sales of Vascepa, or finding some other way to soften the blow it has landed on AMRN, I could see some real federal issues cropping up for the FDA.

Personally, I think it's only the expense and time involved that's keeping AMRN from taking this to court. But circumstances can change in that regard.
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