Thriftycents,
You are absolutely right. As a matter of fact, the trial design was carried out, to a great extent by Dr. Patterson. I remeber in one of his interviews he said that the trial had been "beautifully designed" to probe the efficacy by means of the measurements he already knew would show results (not exactly his words but some to this end). Remember that he had already the Montefiore data
.
Other Outcome Measures:
The measurements above are those that appear on his preprint. Some have asked why PVR is not there. At the time he had only up to day 7 measurements and was developing what he called a new measurement technique. In his own words when I asked him why:
" Insert-tag-hereDay 14 pVL will come out in the revised article. That is what we had when we submitted because we had to develop the super sensitive ddPCR method in short order! "
This would explain why the day 14th PVR was not there and is not in the trial outcomes. However, I have no doubt that these results will be in the efficacy evaluation taking place right now.
The critical point imo is to show FDA the progression of measurements days 0-3-7-14 even if at day 14 most of te patients have recovered (including the placebo ones as well). This will show efficacy, and, more importantly, that we can diminish the hospitalization times and a substancial reduction on progressions to severe-critical in some patients (SAE reduction).
I mistrust FDA but here I must say that we got from they what we wanted as far as trial design end-points and we cannot complain.
If the blood-work measurements replicate those found in Montefiore we are golden. One caveat here though: the Montefiore measurements were taken in S-C patients, here we are talking M-M and, of course, there will be differences on baselines and magnitudes of counts but Leronlimab moa should translate nevertheless.
An exiting week lies ahead.
You are absolutely right. As a matter of fact, the trial design was carried out, to a great extent by Dr. Patterson. I remeber in one of his interviews he said that the trial had been "beautifully designed" to probe the efficacy by means of the measurements he already knew would show results (not exactly his words but some to this end). Remember that he had already the Montefiore data
. Other Outcome Measures:
Quote:Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]
The measurements above are those that appear on his preprint. Some have asked why PVR is not there. At the time he had only up to day 7 measurements and was developing what he called a new measurement technique. In his own words when I asked him why:
" Insert-tag-hereDay 14 pVL will come out in the revised article. That is what we had when we submitted because we had to develop the super sensitive ddPCR method in short order! "
This would explain why the day 14th PVR was not there and is not in the trial outcomes. However, I have no doubt that these results will be in the efficacy evaluation taking place right now.
The critical point imo is to show FDA the progression of measurements days 0-3-7-14 even if at day 14 most of te patients have recovered (including the placebo ones as well). This will show efficacy, and, more importantly, that we can diminish the hospitalization times and a substancial reduction on progressions to severe-critical in some patients (SAE reduction).
I mistrust FDA but here I must say that we got from they what we wanted as far as trial design end-points and we cannot complain.
If the blood-work measurements replicate those found in Montefiore we are golden. One caveat here though: the Montefiore measurements were taken in S-C patients, here we are talking M-M and, of course, there will be differences on baselines and magnitudes of counts but Leronlimab moa should translate nevertheless.
An exiting week lies ahead.
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