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Re: HDGabor post# 52979

Thursday, 07/02/2015 8:12:09 PM

Thursday, July 02, 2015 8:12:09 PM

Post# of 424150
HDG and SST

Unless there is some other interpretation, Amarin successfully completed (finished) the FDA's requirements for the SPA. The FDA acknowledged the completion, by allowing Amerin to submit an application for an sNDA for the mixed dislipidemia indication. As we all know, at a later time, the FDA unilaterally"rescinded" the SPA using some cooked up scientific BS that would have been thrown out by any court in the land.

I do not agree that the "appeals" process was part of the FDA's "requirements.

JMHO

":>) JL

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