Those are my thoughts too Paladin. 

The FDA will have a hard time coming up with reasons to ask for bolt on data as a requirement for NDA filing.  My scenario depends on a) Lipitor/Crestor groups showing statistically similar outcomes, b) renal and dementia sub groups working out, c) the Forest plot being as stunning as Don McCaffrey is hinting, d) only the primary endpoints did not meet the target on a purely statistical basis (I can't figure out what Don meant by "narrow" margins), but everything else worked out as expected.  We already know that the drug is "safe enough for chronic drug use"...which takes care of the FDA's #1 concern (i.e. bad headlines).

I know people think the FDA can't approve us unless the 95% CI threshold has been met, and therefore it is back to the drawing board for more data as far as RVX is concerned.  But I believe the FDA's recent behavior shows that it is itching to approve new drugs.  We have huge needs with a rapidly greying population in the entire Western world.  RVX is by far the best buy 1/get 2 free drugs relatively quickly/plus many more in future free drugs, in front of the FDA.  The only concern may be that the FDA is not sold on the idea of Epigenetics.

My most likely scenario is that the FDA allows RVX to file for an NDA and may add proviso for extra trails and monitoring along with the approval.  So November 14 market action may be a bigger tell than Nov 18, IMHO.