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Posted On: 05/25/2021 5:48:32 PM
Post# of 145875
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Moving on, we all know the over/under 65 results from the CD12. Why isn't the Critical protocol optimized to target the cohort we know we can win an approval with?
The main failure point of CD12 was the 2 dose limitation fixed. The other difference in this trial is no severe which is where the majority of under 65 would have been. Severity not age was the bigger problem. With the Brazil variant a wider age range is going to critical.
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There isn't a single leronlimab indication that is not improved through the administration of the 700mg dose. There's no reason on earth to design a trial using 350mg -- unless your goal is complete and utter failure.
I would have rather have it at all 700 mg. The problem in the mild/moderate trial was the patients that were mild with a low to zero symptom score. Only moderate in this trial, problem eliminated. Primary endpoint - mortality or respiratory failure. A much more specific and objective endpoint than CD10.
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Even the LH trial (which may be characterized as a different disease -- or disease stage) uses 8-consecutive doses of 700mg.
A disease that's unknown to the point that we didn't know if 8 doses would provide only temporary relief or less likely effectuate a cure. We know now that at least in some cases it seems to be a cure. Very fortuitous choice in the number of doses but it is a phase 2 to try and figure these things out.
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