Rex Eupseiphos,
I normally run the same statistical analysis that FDA will do with the data to try and make an idea of where I stand with my investment (and re-allocate accordingly).
At the end of the day, we can talk all day long, but if we do not demonstrate significance (p<0.05) we are toasted and FDA will not approve .
So, in the case of Severe or Critical, the primary end point is survival:
The Montefiore patients where perhaps beyond critical (worse) but, lets assume they where in the trial "normal" population. We know that there have been reported deaths of 88% for this cohort.
https://pubmed.ncbi.nlm.nih.gov/32320003/
The question is: How many need to survive for statistical significance ?? Using a two-tailed test and binomial distribution we obtain that 4 patients survival will yield a p-number of p=0.0239 5 patients 0.00371 and 6 patients 0.000406
So, I will say we obtained statistical significance with the Montefiore patients as per Dr. Patterson paper (if more than 4 are alive at day 28)
Now, if we take the Southern California cohort the (31/32) number is even better (to put it mildly), however not sure if all of them where in the Severe or Critical condition, so I prefer not to run any numbers with this cohort, but, let me just say, if they where mild to moderate, we would crush the p-number (to use NP words) just the same as if they where Severe to Critical.
Any way you slice it we are good. Let's hope the trial shows the same response as the results reported so far.
I normally run the same statistical analysis that FDA will do with the data to try and make an idea of where I stand with my investment (and re-allocate accordingly).
At the end of the day, we can talk all day long, but if we do not demonstrate significance (p<0.05) we are toasted and FDA will not approve .
So, in the case of Severe or Critical, the primary end point is survival:
Quote:Primary Outcome Measures :
All-cause mortality at Day 28
The Montefiore patients where perhaps beyond critical (worse) but, lets assume they where in the trial "normal" population. We know that there have been reported deaths of 88% for this cohort.
https://pubmed.ncbi.nlm.nih.gov/32320003/
The question is: How many need to survive for statistical significance ?? Using a two-tailed test and binomial distribution we obtain that 4 patients survival will yield a p-number of p=0.0239 5 patients 0.00371 and 6 patients 0.000406
So, I will say we obtained statistical significance with the Montefiore patients as per Dr. Patterson paper (if more than 4 are alive at day 28)
Now, if we take the Southern California cohort the (31/32) number is even better (to put it mildly), however not sure if all of them where in the Severe or Critical condition, so I prefer not to run any numbers with this cohort, but, let me just say, if they where mild to moderate, we would crush the p-number (to use NP words) just the same as if they where Severe to Critical.
Any way you slice it we are good. Let's hope the trial shows the same response as the results reported so far.
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