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Re: HDGabor post# 52921

Thursday, 07/02/2015 5:46:55 PM

Thursday, July 02, 2015 5:46:55 PM

Post# of 424135
Amarin did not complete the SPA and never initiated the sNDA (ANCHOR) appeal process.

Yes, they did, and you know they did - they completed the requirements of the SPA, and took the ANCHOR SPA appeal (not sNDA appeal, there is no such thing, a CRL was issued) to the 3rd level, John Jenkins.

Amarin view - it would have been futile to do – is realistic, however not a legal argument / basis to “ignore” the procedure.

That was their basis for abandoning the appeal to the last 2-3 remaining levels at the FDA.

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