Here’s how I view the first set of 10 patients i
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Posted On: 04/02/2020 9:26:28 AM
Here’s how I view the first set of 10 patients injected under the IND: we obviously want as many to survive as possible, but ultimately they are providing proof of concept for the use of leronlimab in COVID19 patients. And so far, according to the PR, the results from 8 out of 10 prove leronlimab can reduce the immune systems response to the virus. That’s outstanding news.
What we don’t know about these 10 patients is how severe their illness was at the time of injection i.e. were they in respiratory distress but not intubated, were they recently intubated or had they already been intubated for a number of days or weeks. That status is important as we know the death rate in intubated COVID19 patients is fairly high (I recall a number around 90% in China, but I don’t remember the reference). Injecting an already intubated patient means that some patients will still die after taking leronlimab. I suspect that at least a few of the 10 injected patients have died or will die because leronlimab was given too late, they have other medical complications, or a combination of the two. I don’t expect CYDY to announce these details until later because it’s a small number of patients, proof of concept is key, and the FDA is watching closely and wants to maintain control. BUT, the FDA pushed CYDY to file the phase 2/3 for severely ill patients which tells me that the FDA believes leronlimab can reduce the death rate based on these first 10 patients.
What the two trials will demonstrate is:
1. How much can leronlimab reduce the death rate in severely ill patients?
2. Can leronlimab reduce the number of ward and/or ICU admissions in the mild/moderate cases? This is most important because if it can, then it will decrease the death rate as well and strain on ventilators, the ICU and overall cost.
What we don’t know about these 10 patients is how severe their illness was at the time of injection i.e. were they in respiratory distress but not intubated, were they recently intubated or had they already been intubated for a number of days or weeks. That status is important as we know the death rate in intubated COVID19 patients is fairly high (I recall a number around 90% in China, but I don’t remember the reference). Injecting an already intubated patient means that some patients will still die after taking leronlimab. I suspect that at least a few of the 10 injected patients have died or will die because leronlimab was given too late, they have other medical complications, or a combination of the two. I don’t expect CYDY to announce these details until later because it’s a small number of patients, proof of concept is key, and the FDA is watching closely and wants to maintain control. BUT, the FDA pushed CYDY to file the phase 2/3 for severely ill patients which tells me that the FDA believes leronlimab can reduce the death rate based on these first 10 patients.
What the two trials will demonstrate is:
1. How much can leronlimab reduce the death rate in severely ill patients?
2. Can leronlimab reduce the number of ward and/or ICU admissions in the mild/moderate cases? This is most important because if it can, then it will decrease the death rate as well and strain on ventilators, the ICU and overall cost.
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