45 deaths is the wrong number. 40, or even maybe 3
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Posted On: 10/09/2020 12:20:26 PM
45 deaths is the wrong number. 40, or even maybe 35 is closer.
Pourhassan printed the number 45 on his interim analysis ASM slide.
This has led everyone to assume that the number of deaths in the interim analysis is 45.
But this is another case of Pourhassan's lack of communication precision resulting in a confusion factor.
CYDY is blinded as to the CD12 interim analysis. They do not get reports on that.
However, CYDY does get reports on SAEs in the entire trial.
The only number of deaths known by CYDY is the SAE deaths, each of which is reported immediately.
And on the day the ASM slide was printed, that number was 45.
On the day of the ASM meeting, Pourhassan said the number was now more like 50.
So the "50" reported on Sept 30 during the ASM includes not only all deaths inside the interim analysis, but also all deaths outside of the interim analysis up to the time of the Sept 30 ASM meeting.
So my guess is that there were no more than 40 and perhaps as few as 35 deaths inside the interim analysis.
Estimating 25% mortality in the placebo arm, that gives about 16 deaths in the placebo arm, leaving 19 for the leronlimab arm.
I think 25% mortality in placebo is too low as that number, culled from other studies, includes people on oxygen who might not be severe/critical.
So I would guess 30% mortality in placebo, which is 19.
If only 35 total in the interim analysis, this leaves 16 for leronlimab. If 40 in total in the interim analysis, this leaves 21 for leronlimab.
The hypothesis that only 35 or 40 deaths occurred inside the interim analysis explains the fact that 45, which was printed on the slide, suggests that the overall mortality was 23%. I am guessing it was lower, at least lower than 20% and perhaps as low as 18%.
Pourhassan printed the number 45 on his interim analysis ASM slide.
This has led everyone to assume that the number of deaths in the interim analysis is 45.
But this is another case of Pourhassan's lack of communication precision resulting in a confusion factor.
CYDY is blinded as to the CD12 interim analysis. They do not get reports on that.
However, CYDY does get reports on SAEs in the entire trial.
The only number of deaths known by CYDY is the SAE deaths, each of which is reported immediately.
And on the day the ASM slide was printed, that number was 45.
On the day of the ASM meeting, Pourhassan said the number was now more like 50.
So the "50" reported on Sept 30 during the ASM includes not only all deaths inside the interim analysis, but also all deaths outside of the interim analysis up to the time of the Sept 30 ASM meeting.
So my guess is that there were no more than 40 and perhaps as few as 35 deaths inside the interim analysis.
Estimating 25% mortality in the placebo arm, that gives about 16 deaths in the placebo arm, leaving 19 for the leronlimab arm.
I think 25% mortality in placebo is too low as that number, culled from other studies, includes people on oxygen who might not be severe/critical.
So I would guess 30% mortality in placebo, which is 19.
If only 35 total in the interim analysis, this leaves 16 for leronlimab. If 40 in total in the interim analysis, this leaves 21 for leronlimab.
The hypothesis that only 35 or 40 deaths occurred inside the interim analysis explains the fact that 45, which was printed on the slide, suggests that the overall mortality was 23%. I am guessing it was lower, at least lower than 20% and perhaps as low as 18%.
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