(Total Views: 651)
Posted On: 12/26/2020 6:57:16 PM
Post# of 153940
“I disagree. They can be aware of how it's going without having enough data to approve.”
The PR clearly outlines that the S/C trial data has yet to be unblinded. We know that the last time the data was looked at was by the DSMC for the 50% analysis. They recommended CYDY continue the trial with no modifications, which was a good sign. The DSMC reports to CYDY, not the FDA. Again, if the FDA is “aware” of the data and approval is imminent as some investors have suggested, then why make CYDY go through the trouble of EINDs and the label expansion, especially while 2K plus die per day?
The PR clearly outlines that the S/C trial data has yet to be unblinded. We know that the last time the data was looked at was by the DSMC for the 50% analysis. They recommended CYDY continue the trial with no modifications, which was a good sign. The DSMC reports to CYDY, not the FDA. Again, if the FDA is “aware” of the data and approval is imminent as some investors have suggested, then why make CYDY go through the trouble of EINDs and the label expansion, especially while 2K plus die per day?
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