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1) The FDA was not “expeditious” in

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north40000 Member Level  Saturday, 05/23/20 11:34:40 AM
Re: FlyFishingStocks post# 275522
Post # of 285930 
1) The FDA was not “expeditious” in approving that ANDA filed by H. That Marine trial-based ANDA was filed over 4-5 years ago by H. Amarin filed its complaint against that ANDA of H in 2016. Judge Du rendered her decision on that complaint in late March 2020.

2) In any event, I do not understand the relation you posit/think exists—that the purported “expeditious” ANDA approval by FDA of H’s ANDA preordains the result you forecast for the Fed. Cir. ruling on the appeal by Amarin. That ANDA approval is NOT in the trial record currently before the Court to my knowledge. Neither litigation party nor Judge Du saw that FDA decision.
Assuming that FDA decision becomes part of the appellate record on review via a motion under FRAP or the Federal Rules of Evidence(any case law on that point in the CAFC?), why does that FDA decision necessarily control the decision of the CAFC?

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