"Let's say that during the Phase 3 trials that took place over the last 3 years, Resverlogix discovers something new...like c reactive protein going down significantly during these Phase 3 trials.  Can they now go back to the data collected during Phase 2, run statistical analysis on that exact item (c reactive protein) and then present it as an original research paper, like they are now doing?  Obviously I don't know if cRP went down or not...I am merely using cRP as an example."

I can't say for sure, but in my opinion Resverlogix is not going to have access to any individual patient blinded data and/or biological samples from BETonMACE until the database is locked. In this case, if they don't have the BETonMACE samples in hand, then they can't perform any additional assays until after the database is locked and they receive these samples. However, many things are already pre-specified to examine in BETonMACE, including hsCRP. I do not know at what point in time that these assays on pre-specified clinical parameters are performed, and I do not know for certain if Resverlogix has access to any of the individual blinded patient data prior to database lock. Once the database is locked and these ~2400 patient blood samples from Phase 3 BETonMACE are in possession by Resverlogix, unblinded, and analyzed, I doubt if Resverlogix will need to go back to the smaller and shorter Phase 2 trials samples. Just my opinion. I honestly don't know the ins and outs of data and biological sample management during clinical trials.

BearDownAZ