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Posted On: 12/16/2020 9:31:47 AM
Post# of 148923
“Well, if you're going to insist on being That Guy, I would totally ignore the DSMC because they have nothing to do with the study, whoever they are.”
DSMB and DSMC are interchangeable and CYDY has always referred to the DSMC in PRs and CCs. I don’t recall them every using DSMB. See below.
From the FDA:
“This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring.”
From the body of yesterday’s PR:
On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint.
The title of the CYDY 75% enrollment PR:
“CytoDyn Reaches Enrollment Target of 293 Patients for 2nd DSMC Interim Analysis of Phase 3 COVID-19 Trial and Expects to Enroll the Remaining 97 Patients in the Next Few Weeks to Complete the Trial This Year.”
DSMB and DSMC are interchangeable and CYDY has always referred to the DSMC in PRs and CCs. I don’t recall them every using DSMB. See below.
From the FDA:
“This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring.”
From the body of yesterday’s PR:
On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint.
The title of the CYDY 75% enrollment PR:
“CytoDyn Reaches Enrollment Target of 293 Patients for 2nd DSMC Interim Analysis of Phase 3 COVID-19 Trial and Expects to Enroll the Remaining 97 Patients in the Next Few Weeks to Complete the Trial This Year.”
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