I agree 100%. To me, everything else is just noise including the not getting Europe fast track. V is applicable to an insanely large population of patients hence the need for an adcom in the US and non-priority review in Europe. It’s like 100% safe, more effective than anything else out there, has just an incredibly extensive trial, has already been approved just needs an expanded label, has data for years to prove its abilities, R-It was designed by and with the FDA so the MO stuff is hogwash, backing from all kinds of groups (ADA) and medical professionals etc etc etc.
I guess what I’m trying to say is - if you are holding AMRN it’s just a question about corruption. In a perfect world with no money under the table or corruption this gets accepted/passes unanimously. Unfortunately, corruption is a reality and the question unlike other bios is not about the drug itself but about it it will get a fair shake out. Everything else is noise.
You are betting on whether or not the FDA is fair and impartial not AMRN anymore.
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