The profound meaning of the ZYESAMI (aviptadil) results and how they apply to us :
From their results:
https://www.neurorxpharma.com/press-releases/...-due-to-c/
So, what does this mean for us??
First, they had a total of 67 Deaths (45 aviptadil + 22 SOC) meaning 203/67=33% (day 28).
Now, let’s assume, for the sake of argument, that aviptadil (AV henceforth) doesn’t do any good whatsoever (acts as a placebo). Let’s assume as well that their distribution of patients (S/C) is the same as ours. This would mean that, in our case, in our placebo group, we will have a total of 130*0.33= 43 deaths .
Therefore, our arm (the one injected with VX) will have: 87 (total deaths) - 43 (SOC)= 44 deaths !!!! This means a p-value of 0.0006486 and a reduction in mortality of 48.8%.
This is assuming that AV and VX trials had the same distribution of patients, of course. If the AV trial had more critical patients that us and, assuming that there are more deaths in this arm (a logical conclusion) this would not be a fair comparison. However, as posted before, their trial exclusion criteria was more stringent that ours and we can reasonably expect a similar outcome.
What I am trying to say is: the results of total deaths in the AV trial are very encouraging for us.
From their results:
https://www.neurorxpharma.com/press-releases/...-due-to-c/
Quote:A total of 203 patients were screened and consented to participate in the study; 136 were given ZYESAMI. while 67 received the standard of care. All patients were evaluated through Day 28 with planned long-term follow-up through day 60. A total of 138 patients (91 ZYESAMI, 47 SOC) survived through Day 28. Ninety-six patients (65 ZYESAMI, 31 SOC) were discharged from the hospital by Day 28. Data analysis per protocol is ongoing. hospital by Day 28. Data analysis per protocol is ongoing.
So, what does this mean for us??
First, they had a total of 67 Deaths (45 aviptadil + 22 SOC) meaning 203/67=33% (day 28).
Now, let’s assume, for the sake of argument, that aviptadil (AV henceforth) doesn’t do any good whatsoever (acts as a placebo). Let’s assume as well that their distribution of patients (S/C) is the same as ours. This would mean that, in our case, in our placebo group, we will have a total of 130*0.33= 43 deaths .
Therefore, our arm (the one injected with VX) will have: 87 (total deaths) - 43 (SOC)= 44 deaths !!!! This means a p-value of 0.0006486 and a reduction in mortality of 48.8%.
This is assuming that AV and VX trials had the same distribution of patients, of course. If the AV trial had more critical patients that us and, assuming that there are more deaths in this arm (a logical conclusion) this would not be a fair comparison. However, as posted before, their trial exclusion criteria was more stringent that ours and we can reasonably expect a similar outcome.
What I am trying to say is: the results of total deaths in the AV trial are very encouraging for us.
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