JL-
I do not want to reopen the discussion about the condition of rescind the SPA, but the basic rule that the Sonsor hasd to introduce evidence that the drug is effective and not FDA would have had to introduce evidence that the relevant drug is ineffective.
I still think that SPA / ANCHOR was dead, it won't be guaranteed won't be on label, however FDA (and Amarin) has to give and get something to reach the settlement.
FDA could offer:
- R-IT:
> additional interim analysis ie.@50% and @75/80%
> increased p value (?) at interim(s), meanwhile stay within statistical meaning
- label:
> Amarin could submit a new, agreed sNDA (not the same as ANCHOR) and FDA will approve it (app. around Aug 2016)
FDA could get:
Vacated Preliminary I. However I think it isn't a best solution for them, since it won't disappear, will remain the part of the Court records. Much better, if the parties request a Permanent I, that will highlights that the case is "specific" and the PI applicable for V only.
It will be a win-win situation. Other Co.s could not backed by this PI, Amarin could stop the R-IT @ 2 additional times, if it won't be stopped at interim, they will have a extended label (not ANCHOR!) in 2016.
Best,
G
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