Ken Chowder requested backup that the FDA turned d
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Posted On: 05/27/2021 4:09:04 PM
Re: KenChowder #91959
Ken Chowder requested backup that the FDA turned down CYDY's request for 4 doses and insisted on 2 doses.
There was an excellent one-hour interview of Dr. Jay Lalezari posted on Savage Minds on 5/18/21. We have noted this interview previously, but if anyone has not taken the time to listen to it, I highly recommend that you do so.
https://savageminds.substack.com/p/jay-lalezari
The following was transcribed from the interview starting at 14:00. Please don't pay too much attention to punctuation or possible errors in one or two words. This was a combination of a speech-to-text extension as well as my attempt to edit, so some errors are likely.
Ken, Dr. Jay said he helped design the study, so the 4 vs. 2 doses comment is not third hand information.
Statistically there was some issues in that the overall, you know, honestly, we knew the drug was working last spring and we knew it based on, you know the plural of anecdotes is not data, but we saw some striking anecdotes, including patients who were on life support but failed all other therapies, who then got Leronlimab and quickly turned around. And so we saw a strong signal that the drug was working, but we saw that signal in patients who were critically ill – intubated.
And I was part of the company as the interim chief medical officer for a while and helped design the studies. And we made one assumption that turned out to be erroneous, and that is, because we saw evidence that it was working in critically ill patients, intubated patients, we assumed that it would also work in patients slightly earlier in the course of illness, specifically patients who were in the hospital on oxygen but not yet intubated. So the Phase 3 study enrolled 394 patients which included both the intubated patients in the ICU as well as hospitalized patients on oxygen.
Well it turns out when we did the analysis of that study, it missed its primary endpoint, and that's where complications come in. First of all, we had proposed that the study treat patients with weekly doses for 4 weeks. Unfortunately, the FDA restricted the study design and we were only able to give two weekly doses. So patients were only covered with drug through day 14, but the FDA insisted that the primary endpoint of the study remain at day 28 even though patients were only treated through day 14, so that's one problem.
The other problem is that there was an unfortunate imbalance in the enrollment of the study such that most of the people who were over 65, and even more of the patients over 75 who were at much greater risk of dying from the infection, they were much more likely to be randomized the drug as opposed to the placebo. So those things combined, as well as the size of the study, the primary endpoint was not met in the Phase 3 study.
There was an excellent one-hour interview of Dr. Jay Lalezari posted on Savage Minds on 5/18/21. We have noted this interview previously, but if anyone has not taken the time to listen to it, I highly recommend that you do so.
https://savageminds.substack.com/p/jay-lalezari
The following was transcribed from the interview starting at 14:00. Please don't pay too much attention to punctuation or possible errors in one or two words. This was a combination of a speech-to-text extension as well as my attempt to edit, so some errors are likely.
Ken, Dr. Jay said he helped design the study, so the 4 vs. 2 doses comment is not third hand information.
Statistically there was some issues in that the overall, you know, honestly, we knew the drug was working last spring and we knew it based on, you know the plural of anecdotes is not data, but we saw some striking anecdotes, including patients who were on life support but failed all other therapies, who then got Leronlimab and quickly turned around. And so we saw a strong signal that the drug was working, but we saw that signal in patients who were critically ill – intubated.
And I was part of the company as the interim chief medical officer for a while and helped design the studies. And we made one assumption that turned out to be erroneous, and that is, because we saw evidence that it was working in critically ill patients, intubated patients, we assumed that it would also work in patients slightly earlier in the course of illness, specifically patients who were in the hospital on oxygen but not yet intubated. So the Phase 3 study enrolled 394 patients which included both the intubated patients in the ICU as well as hospitalized patients on oxygen.
Well it turns out when we did the analysis of that study, it missed its primary endpoint, and that's where complications come in. First of all, we had proposed that the study treat patients with weekly doses for 4 weeks. Unfortunately, the FDA restricted the study design and we were only able to give two weekly doses. So patients were only covered with drug through day 14, but the FDA insisted that the primary endpoint of the study remain at day 28 even though patients were only treated through day 14, so that's one problem.
The other problem is that there was an unfortunate imbalance in the enrollment of the study such that most of the people who were over 65, and even more of the patients over 75 who were at much greater risk of dying from the infection, they were much more likely to be randomized the drug as opposed to the placebo. So those things combined, as well as the size of the study, the primary endpoint was not met in the Phase 3 study.
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