“Which is why you can tell the FDA is giving us
Post# of 153864
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Posted On: 03/10/2021 8:26:52 AM
“Which is why you can tell the FDA is giving us the run around. Instead of bowing down to the FDA Cytodyn needs to sue them. Let an independent board look at the data and when they find it is not deficient throw that burning pile of trash that the FDA calls a decision right back in their laps.”
An independent board would review the combo trial, which finished with 47 patients, and ask for a larger trial, regardless of the significant p value. 47 patients isn’t going to cut it. The reduction in length of hospitalization in CD12 was stat sig in 62 patients and the FDA still asked for a larger trial.
What we’re failing to address is this: CYDY is attempting to combine the combo trial data with data from the mono trial, which superficially, doesn’t seem logical. The FDA appears to be guiding CYDY on how to do this and CYDY can’t get the process correct. If the BLA included a combo trial of 500 patients, we wouldn’t have many issues, but since the BLA is unique, the FDA is being more careful.
An independent board would review the combo trial, which finished with 47 patients, and ask for a larger trial, regardless of the significant p value. 47 patients isn’t going to cut it. The reduction in length of hospitalization in CD12 was stat sig in 62 patients and the FDA still asked for a larger trial.
What we’re failing to address is this: CYDY is attempting to combine the combo trial data with data from the mono trial, which superficially, doesn’t seem logical. The FDA appears to be guiding CYDY on how to do this and CYDY can’t get the process correct. If the BLA included a combo trial of 500 patients, we wouldn’t have many issues, but since the BLA is unique, the FDA is being more careful.
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