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Posted On: 07/31/2020 6:46:18 AM
Post# of 148908
Nothing to worry about. Nothing at all. Our ship has arrived.
From the transcript at
https://www.transcriptshare.com/s/cydy/cytody...te-july-30
Nader Pourhassan, CEO: <...> First and most important update is our covid-19 trials. CD ten study is for mild-to-moderate population.This population is the toughest population to show improvement with any drug.
This is due to most of these patients recover, if not in 4 to 7 days, but for sure 14 days. And to the best of our knowledge, no one has ever received any positive efficacy results better than placebo in this population in a randomized double-blinded FDA trials.
So, in regards to the results of RCD-10 , as of today, we do have positive efficacy results in RCD-10 and and the data is still being evaluated to find more positive aspects. In regards to our primary endpoint, clinical improvement was scored in four categories: fever, body aches, difficulty to breathe, and cough. We have seen improvement in day 3 versus day zero in leronlimab arm as compared to placebo arm.
that is the first major positive result for us. A very important secondary endpoint is called N.E.W.S. 2, which is a upgraded version of N.E.W.S. stands for National Early Warning Score. N.E.W.S. 2 assesses the degree of illness that points out to any need for critical care interventions.
Very very crucial parameter. So again, this indicates this indicator is to determine the degree of illness of patients, whether the patient will be needing critical care intervention by assessing the following parameters: breathing, oxygen saturation, body temperature, blood pressure, and heart rate.
In regards to these very crucial parameters, we have seen good improvements in leronlimab arm compared to placebo arm in all evaluated days. Which is day three, day seven, and day fourteen. We are so delighted with these results.
3rd result of another secondary endpoint is in regards to patients who needed oxygen use and mechanical ventilators. Leronlimab arm beats the placebo arm.
As of today, we are still evaluating a mountain of information to put in our exciting top-line report and present to the FDA as soon as possible. Please note, there are 48 components to cytokine storm panel and three immunological parameters for days zero, three, seven, and fourteen that needs evaluation, and the last thing we want to do is to rush and miss any positive parameters. We hope to have the top line report within 10 days or so. Now what we just explained does not even touch on the number of the SAE events that occurred in this study — a very important parameter. Had previously announced SAEs in leronlimab arms was 64% less than in placebo.
From the transcript at
https://www.transcriptshare.com/s/cydy/cytody...te-july-30
Nader Pourhassan, CEO: <...> First and most important update is our covid-19 trials. CD ten study is for mild-to-moderate population.This population is the toughest population to show improvement with any drug.
This is due to most of these patients recover, if not in 4 to 7 days, but for sure 14 days. And to the best of our knowledge, no one has ever received any positive efficacy results better than placebo in this population in a randomized double-blinded FDA trials.
So, in regards to the results of RCD-10 , as of today, we do have positive efficacy results in RCD-10 and and the data is still being evaluated to find more positive aspects. In regards to our primary endpoint, clinical improvement was scored in four categories: fever, body aches, difficulty to breathe, and cough. We have seen improvement in day 3 versus day zero in leronlimab arm as compared to placebo arm.
that is the first major positive result for us. A very important secondary endpoint is called N.E.W.S. 2, which is a upgraded version of N.E.W.S. stands for National Early Warning Score. N.E.W.S. 2 assesses the degree of illness that points out to any need for critical care interventions.
Very very crucial parameter. So again, this indicates this indicator is to determine the degree of illness of patients, whether the patient will be needing critical care intervention by assessing the following parameters: breathing, oxygen saturation, body temperature, blood pressure, and heart rate.
In regards to these very crucial parameters, we have seen good improvements in leronlimab arm compared to placebo arm in all evaluated days. Which is day three, day seven, and day fourteen. We are so delighted with these results.
3rd result of another secondary endpoint is in regards to patients who needed oxygen use and mechanical ventilators. Leronlimab arm beats the placebo arm.
As of today, we are still evaluating a mountain of information to put in our exciting top-line report and present to the FDA as soon as possible. Please note, there are 48 components to cytokine storm panel and three immunological parameters for days zero, three, seven, and fourteen that needs evaluation, and the last thing we want to do is to rush and miss any positive parameters. We hope to have the top line report within 10 days or so. Now what we just explained does not even touch on the number of the SAE events that occurred in this study — a very important parameter. Had previously announced SAEs in leronlimab arms was 64% less than in placebo.
(10)
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Whatever happens, we have got
Le-Ron-Li-Mab, and they have not.
Le-Ron-Li-Mab, and they have not.
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