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Posted On: 02/24/2021 2:21:48 PM
Post# of 154048
Even if many deaths were outside of 28 days as you suggest, they can still review the data and see the benefit.
However, I disagree with you about the number of deaths in our trial being outside of 28 days. There are many reasons for this:
1) The EIND patients don't support this thesis
2) Many of the trials that we have referenced for mortality numbers shows 30%+ mortality INSIDE of 28 days
3) I believe Leronlimab was used on patients in a more advanced stage than the RLFTF trial, so death was closer.
A patient that is just beginning to progress to critical has longer to live than a patient who has been critical for weeks.
The RLFTF trial is for "critical" patients, take a look at the exclusion criteria. Clearly we were accepting patients that were worse off. (and some that were not as far along in the disease)
I maintain my belief that the recommendation to look at 42 day mortality at 28 days was to possibly help obtain a p value of .005 (2 zeroes) so as to halt the trial at 75% enrollment. At the time that this was offered by the DSMC the enrollment was at a snail pace.
The argument that we may have only had 67 deaths inside of 28 days actually strengthens Leronlimabs efficacy projection, if we assume that there was 30% mortally in placebo, INSIDE of 28 days. Your argument REQUIRES that our mortality figure is dramatically less than that of other comparable trials.
However, I disagree with you about the number of deaths in our trial being outside of 28 days. There are many reasons for this:
1) The EIND patients don't support this thesis
2) Many of the trials that we have referenced for mortality numbers shows 30%+ mortality INSIDE of 28 days
3) I believe Leronlimab was used on patients in a more advanced stage than the RLFTF trial, so death was closer.
A patient that is just beginning to progress to critical has longer to live than a patient who has been critical for weeks.
The RLFTF trial is for "critical" patients, take a look at the exclusion criteria. Clearly we were accepting patients that were worse off. (and some that were not as far along in the disease)
I maintain my belief that the recommendation to look at 42 day mortality at 28 days was to possibly help obtain a p value of .005 (2 zeroes) so as to halt the trial at 75% enrollment. At the time that this was offered by the DSMC the enrollment was at a snail pace.
The argument that we may have only had 67 deaths inside of 28 days actually strengthens Leronlimabs efficacy projection, if we assume that there was 30% mortally in placebo, INSIDE of 28 days. Your argument REQUIRES that our mortality figure is dramatically less than that of other comparable trials.
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