Hi BDAZ,

Just wondering if your experience can give any additional characterization to the discussions which are purportedly taking place between RVX and the FDA regarding BETonMACE.

I would assume that there would be little to no issue with respect to safety given the previous trials' safety record and the fact that the patient population remains very much the same. Am I correct here?

Is there something about the change of emphasis from plaque regression in those with cardiovascular disease to MACE in diabetics with CVD which the FDA would perceive negatively when the cumulative ASSURE/SUSTAIN post hoc analysis would seem to lend support to this change?

I am guessing that most of the discussion would be taking place around trial design and conducting a trial that if/when successful would lead to an approvable drug?

Thanks for any light you can shed.

Perhaps this might be a good topic to dive into on the RVX blog as well.