Good day to all,
Yesterday was an important day in CYDY’s life.
For the first time we demonstrated in a double blinded trial what we already knew: Leronlimab works. And we did it in a very difficult environment: mild to moderate.
Why is this difficult ??? IS very simple, trials are about making contrasts. Contrast between one arm with SOC and another with the drug. Now, if the difference to start with is not pronounced and, worse, if the placebo arm is such that some patients can improve on their own, stablishing a difference is very difficult.
As I mentioned before. Let’s assume that eventually everybody (or almost everybody) gets well. How do I demonstrate that the drug works???
Well, by demonstrating that those taking the drug get well SOONER or don’t get worse.
That is precisely what we did in our trial: We demonstrated improvement at day 3 and statistical significance in the NEWS2 score at day 14.
Now, the naysayers would say: where is the p-value at day 14 for the primary point ?? The point here is that as we are contrasting two groups with little contrast to start with AND that can improve on their own, is extremely difficult to stablish the difference, both in numbers and in symptoms as time goes by. I say numbers because at the end of day 14 there might not be enough patients with symptoms to have enough statistical power.
Our results are extraordinary and that is why I added more shares to my already large position (BTW for those that PMed me saying that I was “bluffing” when I mentioned I had bought some more shares here is the proof that I put my pocket where my mouth is https://drive.google.com/file/d/1X_-1EWvpegV_...p=sharing).
As Dr. Patterson said: we have a very strong case for approval. This if the FDA is impartial and un-tainted.
That is another story altogether.
Yesterday was an important day in CYDY’s life.
For the first time we demonstrated in a double blinded trial what we already knew: Leronlimab works. And we did it in a very difficult environment: mild to moderate.
Why is this difficult ??? IS very simple, trials are about making contrasts. Contrast between one arm with SOC and another with the drug. Now, if the difference to start with is not pronounced and, worse, if the placebo arm is such that some patients can improve on their own, stablishing a difference is very difficult.
As I mentioned before. Let’s assume that eventually everybody (or almost everybody) gets well. How do I demonstrate that the drug works???
Well, by demonstrating that those taking the drug get well SOONER or don’t get worse.
That is precisely what we did in our trial: We demonstrated improvement at day 3 and statistical significance in the NEWS2 score at day 14.
Quote:In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
Quote:In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
Now, the naysayers would say: where is the p-value at day 14 for the primary point ?? The point here is that as we are contrasting two groups with little contrast to start with AND that can improve on their own, is extremely difficult to stablish the difference, both in numbers and in symptoms as time goes by. I say numbers because at the end of day 14 there might not be enough patients with symptoms to have enough statistical power.
Our results are extraordinary and that is why I added more shares to my already large position (BTW for those that PMed me saying that I was “bluffing” when I mentioned I had bought some more shares here is the proof that I put my pocket where my mouth is https://drive.google.com/file/d/1X_-1EWvpegV_...p=sharing).
As Dr. Patterson said: we have a very strong case for approval. This if the FDA is impartial and un-tainted.
That is another story altogether.
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