Bruce, you are too much of a worry wart :)
First I separate ADcom from approval decision.
When the briefing doc comes out 2 days before the Adcom event, we'll have an idea of the FDA thinking.
Until then, I'll go with the common understanding that Adcoms are for safety and efficacy. Is V safe ? Does V reduce trig levels between 200 and 500 ?
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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.
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It is a very good point. However, let's compare CV and diabetes. I have been very lucky with diabetes and made serious $ with amy and mnkd.
The current marker for DM is HbAc1. If your drug shows it can reduce Ac1 then you get approved even with some safety issues, whether real or not.
However I can apply the same argument against the Ac1 marker. It looks like more and more that keeping Ac1 below certain levels is not enough. People are still going blind, get kidney failures etc.. Those complications could be caused by lack of compliance as injections many times a day are a pain or as the evidence is accumulating over the years that the real damage is from the postprandial glucose spike and that most of the current medication available does very little to correct the situation.
Hence the incentive for the Ultra Fast Insulin generation of DM drugs which mimics better the action of a normal pancreas.
The only reason I can think of the FDA not following a positive Adcom recommendation is that it believes that reducing trig levels between 200-500 is completely useless medically and thus a waste of money and effort. I don't see that happening .
BTW, I value DD opinions too. But not about everything :). He has missed out on quite few that went parabolic. But I never argue with him when it comes to HIV stuff.
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