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Luv seeing that word!If you examine the four links I’ve provided, you’ll get very excited as to why the reference to “efficacy” is so important! Many thanks to the RVX team for providing that! Still hoping that Big Pharma bites soon, as the news continues to be very encouraging! News Release Issued: Dec 5, 2016 (10:13am MST) Resverlogix Announces Second Positive Recommendation From Data Safety Monitoring Board For Phase 3 Study of Apabetalone (RVX-208) A data review by the independent Data Safety Monitoring Board resulted in a recommendation for the BETonMACE trial to continue as planned without any modification. CALGARY, Dec. 5, 2016 /CNW/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a second planned safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified. The DSMB will conduct additional periodic reviews and will also perform a futility assessment once 125 adjudicated major adverse cardiac events (MACE) have been observed. Resverlogix, the clinical steering committee, and all investigators remain blinded to the actual safety and efficacy results. (Resverlogix) http://www.ninds.nih.gov/research/clinical_research/policies/data_safety_monitoring.htm https://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm http://www.avac.org/data-safety-monitoring-boards https://catalyst.harvard.edu/pdf/regulatory/DSMB-P_Guidance.pdf F6 |
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