Since we're re-visiting SPA issues, here's some questions that have been nagging me lately:
Most of us on this board feel the FDA intentionally terminated the SPA using a willful misinterpretation of their congressional directive. Citing concerns that reduced T's would not have an effect on outcomes seems very specious to me. I think a judge would find that the whole justification for the SPA is to allow drugs to come to market earlier - as long as they were meeting agreed-upon preliminary targets. Why else would there even be an SPA?
Next question: Although AMRN has publicly stated they are not pursuing a final appeal, does it necessarily mean they have not exhausted the appeal process? I think a case can be made that if the penultimate appeal involved the same party involved in a final appeal - it's a redundant appeals process. Why would an appeals process involve appealing twice to the same party? Perhaps AMRN's counsel holds the same opinion, privately.
Third and final SPA-related question: we are also assuming NCE decision has little weight on ultimate success of the company, and that the NCE and SPA are completely unrelated matters. However, if during the NCE suit discovery and testimony process, additional light is shed on FDA's regulatory excesses and interpretive malfunctions, is it not possible that a favorable ruling would give AMRN additional leverage in reversing the SPA damage, as well?
Two final notes: I really don't think the FDA is negotiating much of anything with AMRN. I think they've drawn the line in the sand, and are stuck with defending it. Hopefully NCE lawsuit results will alter that stance!
I've been reading all posts diligently, and welcome JL's return, as well as HD, BB, Zu, BioChica, Hitchie, Epi, Dancing, and other good posters. Hopefully my questions spur some interesting discussion...
