Hi JL... been in touch w/ DD... expect he won't mind me share his opinions (which I respect).
gs: AMRN continues to climb into 16 Oct Adcom...
I see a positive vote here. p3 trial met primary and secondary endpoints and drug is safe. thots on adcom?
DD: Panel could go either way, IMO, given the failure of so many CV drugs to affect actual outcomes even though they improve surrogate markets. The real question is what the FDA will do. They don't have to follow the panel.
gs: I just don't see why the panel would go negative given trial results and safety profile... Isn't this approval process all about efficacy and safety? Also AMRN is substantially underway with Outcome study as requested by FDA. thots / comments?
DD:A lot of cardiologists no longer believe that surrogate endpoints (such as triglycerides, HDL, etc.) predict risk of CV events. Waiting for results of REDUCE-IT seems like a kneejerk kind of response to the question. All told, I expect the panel to be positive, but not unanimous.
Your thoughts JL?
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