Because AMRN told us the goal was a final ruling. Did you listen to the last CC? That is apparently their goal and they let the FDA still run things. I am not the only person upset about this, others have also expressed their vehement frustration as well. It could be about language. It could be AMRN getting played by the FDA who keeps dangling carrots that will NEVER materialize. But, it is just another instance of AMRN being totally incapable of actually accomplishing something. This should have been a quite simple process: are you willing to give us a label expansion? The second the FDA says no or wavers in ambiguity, it should have been back to court. Done. Very simple. And yet this goes on and on. Someone wants to stall things, and the FDA is the one that benefits from no final ruling, correct?
Your whole "it is REDCUE-IT data related" makes zero sense. What does AMRN get extra that they wouldn't have already gotten? REDUCE-IT data is coming in regardless of whether or not they settle. The settlement has nothing to do with what the data says. So what exactly are they getting? Oh you are the proponent that the FDA will actually review the application faster, right? Ha....and I am the naive one? I, and AMRN, shouldn't be trusting the FDA to abide by their word or promises, that could be broken so fast you didn't even know what happened. They will never review the Vascepa application quickly, and you are dumb if you think they will. Plus the most likely outcome is no stoop at interim, so what do you think happens then?
Or do you think AMRN still fears the FDA, which explains why they are playing so nice with them? Sure is a possibility.
Either way AMRN is getting run over by the FDA in this instance. I can PROMISE you that AMRN is the one being manipulated by the FDA. It is so obvious I am sorry you cannot see it. As I laid out, this should have been quite simple to AMRN, and AMRN should have already taken this back to court months ago.
