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Re: Biobillionair post# 35397

Friday, 09/26/2014 6:57:43 AM

Friday, September 26, 2014 6:57:43 AM

Post# of 430695
"Do you believe a CRL is being held until SPA appeal is finished?" - FDA maintained the SPA appeal and sNDA are two separate matters and did not address the ANCHOR sNDA (Amarin CC) - I do not think they changed their approach / mind now

SPA vs CRL - yes. Without SPA they could be more "flexible"

Oct 12 - I could imagine that Amarin send a declaration (informal drop), however I do not know (did not and won't check) that they could or could not drop the appeal legally before the end of the official expiration. I don't think they will appeal to JW
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