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Re: sts66 post# 52977

Thursday, 07/02/2015 6:26:30 PM

Thursday, July 02, 2015 6:26:30 PM

Post# of 423945
sts-

Amarin could not complete the SPA. They could complete ANCHOR study acc. to the SPA and yes they did. Based on this I think that "Amarin did not complete the SPA and never initiated the sNDA (ANCHOR) appeal process." could not be interpreted in any other way than: Amarin did not complete the SPA [appeal process] and never initiated the sNDA (ANCHOR) appeal process.

not sNDA appeal, there is no such thing, a CRL was issued


Please inform Amarin, since they do not know this ... "Amarin determined that appeal of the FDA’s decision in the CRL would be futile." - Doc 01 (15-cv-3588-PAE-JLC)

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


Yes, that was the basis of their decision, but it is not enough to initiate the suit w/o completion of the appeal process.

to quote JL, "do you ever read anyone else's posts?" - your part A is nearly identical to stuff I've already posted - but I won't complain, just reinforces the issues here.


??? You posted 7 since you realized the Docs (here) and none of them was a summary of the Docs. Which is the post where you summarized the Doc 64-67?
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