Yes... CD12 was billed as a PIII but the way it was eventually populated and the imbalances (only 62 critical, especially) ended up making it more of a PII.
I don't suffer from stockholm syndrome, at all. But the FDA granting LLMab (an "HIV drug"
both a PII and PIII last April for Covid-19 wan't standard operating procedure. Knowing what endpoints to aim for wasn't a slam dunk, no trials had completed by then.
So this is critical:
If this trial is done a bit more deliberately, it could be relatively quick and much more clear an efficacy signal. I think it will be. All you have to do is tell any critical, mechanically ventilated patient "we have something promising" and they will sign right up. I'm more than a little pissed at the 1:1 ratio, but whatever it takes to get this going.
I don't suffer from stockholm syndrome, at all. But the FDA granting LLMab (an "HIV drug"
both a PII and PIII last April for Covid-19 wan't standard operating procedure. Knowing what endpoints to aim for wasn't a slam dunk, no trials had completed by then. So this is critical:
Quote:1) Carry out the 140 patients trial with a different end point. If we target Length of Hospital stay stay we have an assured approval (that is what GILD did) and we have a p-value 0.005 (adjusted for stratification factor and age).
If this trial is done a bit more deliberately, it could be relatively quick and much more clear an efficacy signal. I think it will be. All you have to do is tell any critical, mechanically ventilated patient "we have something promising" and they will sign right up. I'm more than a little pissed at the 1:1 ratio, but whatever it takes to get this going.
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