I concur that something is very suspicious regarding the change If amrn was talking to FDA as much as they implied it is hard to imagine that they weren't aware. However, the tone of bias in the FDA staff was so obvious that it was clear that they had an agenda and truely could have blindsided AMRN. It would seem that if the science had changed as the FDA indicated then AMRN should have been informed some time ago and the ADCOm postponed or cancelled or the indication changed. At a mimimun, the focus of the technical presentation at the ADCOM would have been on how the other studies were not relevant to Vasepa and how the science, theory of EPA and CV events is different than is the case for other lipin indicator impacting drugs and that CV response is both dose and TGL level dependent so other study results are not simply transferrable to Vasepa.
Either gross incompetance or intentional deception or both.
And that panelist who didn't have a clue about off label use isses re insurance etc proved she had no business being on the panel.
AMRN should set a 45 day window to solicit partnering offers to complete reducit it and if none are available then they should indicate their intention to discontinue it. There is no way absent an early study termination that they can afford to complete it alone and the science might change again anyway or FDA could find a new reason to not support it they are truely being influenced by BP. Reduce-it isn't two years away, it is 4+ years away with study completion, analysis, PUDFA time etc. not possible GIA.
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