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Message: So is it RVX or the CRO,...

"So do we know for sure, once the DBL occurs, is it us or the CRO who comes up with the TLD results that are then announced,...?"

From the design and rationale paper:

"Study organization: The BETonMACE trial was conceived by the independent academic Executive Steering Committee in conjunction with the sponsor. The Executive Committee, composed of three academic cardiologists, a nephrologist, a lipidologist, an endocrinologist, and non-voting sponsor representatives, is responsible for oversight and guidance of the study. An independent academic statistician will perform or confirm all statistical analyses of the final data. Academic national leaders oversee protocol implementation and site performance in each participating country. Site and data management and analysis are coordinated by PPD Ltd."

My understanding and interpretation is that the CRO (PPD Ltd.) will send the locked database to an independent data analysis team to perform the pre-specified data analysis plan. Once analysis is complete, the results will be sent to the sponsor (Resverlogix) and Executive Committee (same as Clinical Steering Committee?), who will then decide what data to include in the top-line data announcement and compose the top-line data announcement. Resverlogix estimated that after database lock, top-line data will be available and announced in about 2 weeks. So it may take the data analysis team a good deal of time (up to 2 weeks) to finish analzyzing the locked data. All just my opinion. 

BearDownAZ

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