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Posted On: 08/03/2021 3:18:16 PM
Post# of 148918
What is inaccurate? The headline, Hulk.
Here's what I wrote to the pubescent Jason Mount, the author of the Endpoints piece:
writing in response to your article about Cytodyn, and its drug Leronlimab, which you characterize as "a failed Covid-19 drug."
I hope that (but wonder if) you have looked at the details of the two Covid-19 trials where Leronlimab was tested. One of them, CD10, was for mild-to-moderate patients; the drug achieved statistical significance for a secondary endpoint, the "NEWS 2" score, which measures a group of symptoms. The other trial, CD12, was for severe to critical patients. The company attempted an ambitious primary endpoint, overall mortality after 28 days; it did achieve a lower overall mortality at that point, but not enough for statistical significance.
Two things of note about that trial. First, the FDA mandated that the patients receive only two weekly doses of the drug -- Cytodyn had requested a protocol with four doses. The drug has a half life of 10 days. So the drug was delivered on Day 1 and Day 8; by Day 18 the drug was effectively no longer in the patients' bodies. On Day 14, the drug achieved an 82% reduction in mortality for critically ill COVID-19 patients -- that is statistically significant (even though the trial was small), and also the best result ever achieved in a Covid trial, far surpassing Remdesivir's results. However, this was not the primary endpoint; mortality on Day 28 was the primary, and effectively a two-dose treatment was measuring Standard of Care vs. placebo (the latter is what the Leronlimab effectively became, 21 days after the second dose had been administered).
The other thing to mention about the trial is that randomness failed in distributing patients. There were proportionately more patients in the Leronlimab arm who were critically ill and over 65 -- those more likely to die. If the numbers had been adjusted to even out those numbers, Leronlimab would have achieved statistical significance.
In other words, characterizing Leronlimab as a "failed Covid-19 drug" is simply incorrect. The FDA has shown a willingness to see more numbers, and the company is now initiating two further trials, one for 612 severe patients and one for 316 patients.
I would be grateful if you would change your wording and describe Leronlimab as a drug that did not attain statistical significance for its primary endpoint in its two trials. If you added that it continues to test the drug with new trials, with different primary endpoints, that would in truth be more accurate.
Here's what I wrote to the pubescent Jason Mount, the author of the Endpoints piece:
writing in response to your article about Cytodyn, and its drug Leronlimab, which you characterize as "a failed Covid-19 drug."
I hope that (but wonder if) you have looked at the details of the two Covid-19 trials where Leronlimab was tested. One of them, CD10, was for mild-to-moderate patients; the drug achieved statistical significance for a secondary endpoint, the "NEWS 2" score, which measures a group of symptoms. The other trial, CD12, was for severe to critical patients. The company attempted an ambitious primary endpoint, overall mortality after 28 days; it did achieve a lower overall mortality at that point, but not enough for statistical significance.
Two things of note about that trial. First, the FDA mandated that the patients receive only two weekly doses of the drug -- Cytodyn had requested a protocol with four doses. The drug has a half life of 10 days. So the drug was delivered on Day 1 and Day 8; by Day 18 the drug was effectively no longer in the patients' bodies. On Day 14, the drug achieved an 82% reduction in mortality for critically ill COVID-19 patients -- that is statistically significant (even though the trial was small), and also the best result ever achieved in a Covid trial, far surpassing Remdesivir's results. However, this was not the primary endpoint; mortality on Day 28 was the primary, and effectively a two-dose treatment was measuring Standard of Care vs. placebo (the latter is what the Leronlimab effectively became, 21 days after the second dose had been administered).
The other thing to mention about the trial is that randomness failed in distributing patients. There were proportionately more patients in the Leronlimab arm who were critically ill and over 65 -- those more likely to die. If the numbers had been adjusted to even out those numbers, Leronlimab would have achieved statistical significance.
In other words, characterizing Leronlimab as a "failed Covid-19 drug" is simply incorrect. The FDA has shown a willingness to see more numbers, and the company is now initiating two further trials, one for 612 severe patients and one for 316 patients.
I would be grateful if you would change your wording and describe Leronlimab as a drug that did not attain statistical significance for its primary endpoint in its two trials. If you added that it continues to test the drug with new trials, with different primary endpoints, that would in truth be more accurate.
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