“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.