“maybe the DSMC has given hints to the FDA regar
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Posted On: 12/26/2020 9:48:03 PM
“maybe the DSMC has given hints to the FDA regarding the strong efficacy.”
The DSMC is created by, and reports to, CYDY. I did extensive research on the purpose and processes of a DSMC (there are numerous articles by the FDA, NIH, and official guidance on the establishment and function of a DSMC) and I didn’t find any information indicating that a DSMC reports, for any reason, directly to the FDA. If the DSMC notes efficacy and believes the data could result in a halt, they report that information to the company and the company uses that information to make a decision (I.e. file for an EUA, etc.). None of the PRs for the therapeutics or vaccines already given EUA for COVID indicate that the DSMC/DSMB was communicating directly with the FDA. In Mesoblast’s PR announcing the failure of their drug for the S/C population, they specifically stated that the DSMB found at the 75% interim analysis that the trial would not meet its primary endpoint and recommended the trial be halted. The FDA is not mentioned anywhere in that PR.
The DSMC is created by, and reports to, CYDY. I did extensive research on the purpose and processes of a DSMC (there are numerous articles by the FDA, NIH, and official guidance on the establishment and function of a DSMC) and I didn’t find any information indicating that a DSMC reports, for any reason, directly to the FDA. If the DSMC notes efficacy and believes the data could result in a halt, they report that information to the company and the company uses that information to make a decision (I.e. file for an EUA, etc.). None of the PRs for the therapeutics or vaccines already given EUA for COVID indicate that the DSMC/DSMB was communicating directly with the FDA. In Mesoblast’s PR announcing the failure of their drug for the S/C population, they specifically stated that the DSMB found at the 75% interim analysis that the trial would not meet its primary endpoint and recommended the trial be halted. The FDA is not mentioned anywhere in that PR.
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