Amarin Corp Plc (AMRN)

[redlyon]

JanetW's membership on the CDER Medical Policy Council may prove to be yet another awkward corner FDA has painted itself into. If AMRN has cause to appeal beyond JJ's level, the independence of review at the next level (CDER Director) is so transparently compromised by JanetW's intimate participation in JJ's decision that the only remaining independent appeal level within FDA would be the Commissioner herself. Neither appeal level will be comfortable politically for FDA as JanetW has obviously already participated in reviewing Vasepa and Madame Commissioner must lug hubby's HF baggage packed with those 147,000 shares of AMRN.

IMO this conundrum tilts the JJ appeal decision in AMRN's direction--how much I don't know, but FDA higher-ups will want to ensure that this is the LAST appeal of this increasing sticky tar baby. It may make the JJ decision slower than we would wish, but it's going to be good enough to deter further appeals. JMHO