Back when the 2nd denial was announced in April I added up the time to final decision and it was 3 * 90 days (Jenkins, Woodcock, Hamburg) and figured Hamburg had until Dec 2014 to decide, assuming all 3 took the "guidance" of deciding in 90 days or less - but they can take longer if they want.
We all know the buck stops with Hamburg, but there are two more levels below her in the appeal process, each one should have to officially deny before it reaches her desk - BB said it's on her desk right now - big diff.
From AMRN's Q1 investor presentation, timeline so far - I believe they don't mention appealing above Jenkins for a couple reasons: 1) don't want to appear to go over his head until he decides, and 2) don't want to make it seem certain that he will deny appeal, although we're all pretty sure he will.
Oct 2013: FDA advisory committee voted “no” on whether Vascepa’s effects in ANCHOR were sufficient to grant approval on an ANCHOR indication prior to the completion of REDUCE-IT. Result relied on failed outcome studies of niacin and fibrates, FDA’s lack of
confidence in connection between TGs and CV risk reduction; ANCHOR SPA agreement rescinded.
* Dec 2013: PDUFA date passed without FDA decision on ANCHOR sNDA while FDA considers SPA rescission appeal
* Jan-Apr. 2014: FDA Review Division and ODE II uphold SPA rescission after appeals
PATH FORWARD
* Appealing to higher level, John Jenkins, MD, Director, Office of New Drugs in mid-’14
* If appeal effort is not successful, Amarin may pursue judicial relief under First Amendment
* Uphill battle but Amarin believes that patient care would benefit from Vascepa approval and also that Amarin has valid legal, clinical and regulatory arguments
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