Amarin Corp Plc (AMRN)

[ggwpq]

Great post from cyliu of yahoo msg board :

6/4/14 FDA: " ... complex issues requiring extensive review and analysis by Agency officials."

7/30/14 FDA: "... aware of the significant Congressional and stakeholder interest in the Agency's decision on this matter. FDA is making every effort to resolve the matter as expeditiously as possible, while also ensuring that the Agency's decision reflects a full consideration of the issues brought to our attention in light of all the available scientific evidence."

8/7/14 AMRN PR: "... The FDA's Office of New Drugs recently notified Amarin that it requires additional time to respond to the company's appeal of the rescission of the ANCHOR clinical trial special protocol assessment agreement. Amarin now expects to receive a substantive response to its appeal by mid-September."

Seemingly, the two sides are communicating intensively over certain substantial issues -- restating the SPA or ratifying a substantively changed label (I lean to the later one).