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Biobillionair

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Biobillionair

Re: sts66 post# 22290

Saturday, 11/30/2013 4:29:45 PM

Saturday, November 30, 2013 4:29:45 PM

Post# of 426865
STS negotiation of labels is a fluid process after the acceptance of the application and 74 day letter. The "preg" 8.3 updated label is sNDA 9, we're missing sNDA 5,6,7, and 8. If not agreed on they'll never actually be posted on Drugs@FDA. Fact, within 14 days of 11-25, we'll see what number (revision/negotiation) 9-19-2013 corresponds to. The 8.3 update has zero to with the 9-19 sNDA update, 8.3 was sent by the FDA on 11-4, agreed to on 11-12 by Amarin and updated within the 14 day regulation period. 8.3 was however a prerequisite for the approval of sNDA #? Dated 9-19.

This is really confusing and took two days to sort through Amarin press releases, and tons of unrelated sNDA approvals.

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