Outcome doesn't matter? Why would that be? In any case, from what other folks have posted about bonus-related issues for execs, it appears they plan to go the easy route like many drug companies go - get a peds waiver. Not exactly sure how the process works, have seen language like "get FDA to request ped waiver", which on the surface looks like the FDA must request a waiver from AMRN, but surely AMRN has to ask the FDA for a waiver in reality? ARNA got a peds waiver from the EMA (not FDA that I'm aware of) for their Lorc MAA.
Good thing Vascepa isn't a SSRI or similar - fed peds waivers for those drugs have caused a lot of havoc, including teenage suicides - the waiver process is flawed in certain cases. Even worse, some of those BP's even had trial data showing that some of the drugs increased suicidal thoughts it adults and hid it from the public until lawsuits forced them to admit what they knew, Cymbalta for instance.
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