On the mild to moderate trial (CD10):
Just recently I was aware of the real numbers of the M-M trial that will give us an possible indication as of why FDA would not approve LL or give us EUA (not yet) on basis of NEWS2 score.
https://drive.google.com/file/d/1dlREuo-DGs9D...sp=sharing
We had a total of 84 patients. 8 had a score of <1, 31 had 1 or more and less than 4 and 45 had a score of 4 or more .
Noe let's think about this: we had a total of 39 patients with scores less than 4, let's call them mild and 45 with moderate symptoms .
We obtained statistical significance with this cohort (p-value=0.023), however the problem is the power of the calculation. That is, the false negative error (Type II) with mere 45 patients (15 control, 30 leronlimab).
We don't know what kind of scores means and standard deviation we obtained, let's assume that they were 6 for LL and 7 placebo with a SD of 1.4
The required sample size is 62:31 (LL:placebo) for a power of 90% (26:46 for 80%).
So we will need approximately 100 patients if we were to do a trial for moderate with acceptable statistical power.
The results we obtained in our M2M trial were relevant, however we had too few patients and, worse, many with almost no symptoms. To visualize this, let's assume I go to the hospital because I am coughing once in a while (Score=1), I am in the mild group !!! or have a little temperature. The same.
So, our M2M trial was designed to treat people starting with flu-like symptoms (and some that did not have anything, 8 patients with score less than 1 , meaning 0???, I believe they mean =1 ).
It is unbelievable that we even got some results ... In retrospective, I am not sure what we were trying to probe here and we shouldn't have done the trial like this. Of course, I am here unfairly playing Monday Coach and J.L. did not know then what he knows now. What is amazing is we treated some people that did not have any "serious" symptoms to speak of.
If we do a new trial for moderate we will need at least 100 people (if FDA decides not to give us extended access after our CD12 results).
Just recently I was aware of the real numbers of the M-M trial that will give us an possible indication as of why FDA would not approve LL or give us EUA (not yet) on basis of NEWS2 score.
https://drive.google.com/file/d/1dlREuo-DGs9D...sp=sharing
We had a total of 84 patients. 8 had a score of <1, 31 had 1 or more and less than 4 and 45 had a score of 4 or more .
Noe let's think about this: we had a total of 39 patients with scores less than 4, let's call them mild and 45 with moderate symptoms .
We obtained statistical significance with this cohort (p-value=0.023), however the problem is the power of the calculation. That is, the false negative error (Type II) with mere 45 patients (15 control, 30 leronlimab).
We don't know what kind of scores means and standard deviation we obtained, let's assume that they were 6 for LL and 7 placebo with a SD of 1.4
The required sample size is 62:31 (LL:placebo) for a power of 90% (26:46 for 80%).
So we will need approximately 100 patients if we were to do a trial for moderate with acceptable statistical power.
The results we obtained in our M2M trial were relevant, however we had too few patients and, worse, many with almost no symptoms. To visualize this, let's assume I go to the hospital because I am coughing once in a while (Score=1), I am in the mild group !!! or have a little temperature. The same.
So, our M2M trial was designed to treat people starting with flu-like symptoms (and some that did not have anything, 8 patients with score less than 1 , meaning 0???, I believe they mean =1 ).
It is unbelievable that we even got some results ... In retrospective, I am not sure what we were trying to probe here and we shouldn't have done the trial like this. Of course, I am here unfairly playing Monday Coach and J.L. did not know then what he knows now. What is amazing is we treated some people that did not have any "serious" symptoms to speak of.
If we do a new trial for moderate we will need at least 100 people (if FDA decides not to give us extended access after our CD12 results).
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