“The FDA approved the study as a phase 3 interventional and then allowed a BLA to be submitted based on that patient number.”
If your above statement was accurate, combo would’ve been approved years ago. But here we are 3 years later, still waiting on the BLA to be completed. There has been something wrong the entire time (trial size is one of those issues) and that’s why the FDA asked for more data. There’s nearly zero chance of a 47 patient trial getting approval by the FDA for HIV, regardless if its was approved by the FDA, a phase 3, and has a stat sig p value.
The FDA approved CD12 and the 62 patient, stat sig endpoint needs a larger trial. In the case of the combo BLA, the FDA agreed to accept data from the mono trial to make to combo trial data more robust.
If your above statement was accurate, combo would’ve been approved years ago. But here we are 3 years later, still waiting on the BLA to be completed. There has been something wrong the entire time (trial size is one of those issues) and that’s why the FDA asked for more data. There’s nearly zero chance of a 47 patient trial getting approval by the FDA for HIV, regardless if its was approved by the FDA, a phase 3, and has a stat sig p value.
The FDA approved CD12 and the 62 patient, stat sig endpoint needs a larger trial. In the case of the combo BLA, the FDA agreed to accept data from the mono trial to make to combo trial data more robust.
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