"I will toss in another question...something DM mentioned during the presentation, EGFR.  Would the company, the steering committee, the DSMB....would they have access to general data on EGFR or any other secondary endpoints?"

Yes, I am sure that the DSMB would have access to the unblinded secondary outcomes/clinical measures, including the eGFR. Resverlogix and the steering committee would remain blinded. Unless something in the secondary outcomes/clinical measures presents a safety problem, I doubt that it would influence any DSMB recommendations at safety checks and/or SSRA. In my opinion, any preliminary findings in the secondary outcomes will not influence the SSRA, which is centered upon the 3-point MACE primary outcome. However, if the # of total patients in BETonMACE w/ renal or cognitive disease are below the original # projected, then there may be a recommendation to specifically recruit more of these folks. I don't claim to be a pro, but this is my take on it.

BearDownAZ