Jakafi placebo mortality 70%? LL half-life 3 or 10 days?
Very nice move in CYDY since 14 day mortality and other news.
Maybe someone can help riddle me this:
How in the world can Incyte's severe Covid study have placebo mortality of 70% (those on mechanical ventilation, not ECMO, pAO2/FiO2 <300) while our study (those on mechanical ventilation or ECMO, pAO2/FiO2 150-300) had only 39% mortality; Ordinal Scale=2 group)?
https://finance.yahoo.com/news/incyte-announc...00074.html
Makes it so difficult to compare trial results when there is so much difference in SOC. Can anyone spot any differences in the populations studied that would explain the huge disparity in SOC/placebo mortality?
Jakafi Covid ARDS study:
https:/clinicaltrials.gov/ct2/show/NCT04377620
Leronlimab s/c study:
https://clinicaltrials.gov/ct2/show/NCT04347239
Overall, Jakafi study considered a "failure" but results look very good. They just missed statistical significance for each dose (OR goes up just over 1.0 to 1.02x), but when pooling both doses, reduced mortality from 71% to 54% (barely stat. sig, OR top 0.996) but post hoc to combine, so will see what FDA decides to do regarding EUA for them.
Second question for the board: Does anyone understand why the IV and subcutaneous dosing trials reported PRO140/LL half-life around 3 days, but CYDY reported without any explanation on 5/6/19 that they had a new "understanding," and yeah, now half-life is really 10 days?
https://www.cytodyn.com/investors/news-events...ab-pro-140
IV dosing:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2944554/
subcutaneous dosing:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2856743/
What changed in the understanding of half-life?
In any event, it makes good sense to go to IV and from 2 to 4 doses for critical Covid in CD16.
Very nice move in CYDY since 14 day mortality and other news.
Maybe someone can help riddle me this:
How in the world can Incyte's severe Covid study have placebo mortality of 70% (those on mechanical ventilation, not ECMO, pAO2/FiO2 <300) while our study (those on mechanical ventilation or ECMO, pAO2/FiO2 150-300) had only 39% mortality; Ordinal Scale=2 group)?
https://finance.yahoo.com/news/incyte-announc...00074.html
Makes it so difficult to compare trial results when there is so much difference in SOC. Can anyone spot any differences in the populations studied that would explain the huge disparity in SOC/placebo mortality?
Jakafi Covid ARDS study:
https:/clinicaltrials.gov/ct2/show/NCT04377620
Leronlimab s/c study:
https://clinicaltrials.gov/ct2/show/NCT04347239
Overall, Jakafi study considered a "failure" but results look very good. They just missed statistical significance for each dose (OR goes up just over 1.0 to 1.02x), but when pooling both doses, reduced mortality from 71% to 54% (barely stat. sig, OR top 0.996) but post hoc to combine, so will see what FDA decides to do regarding EUA for them.
Second question for the board: Does anyone understand why the IV and subcutaneous dosing trials reported PRO140/LL half-life around 3 days, but CYDY reported without any explanation on 5/6/19 that they had a new "understanding," and yeah, now half-life is really 10 days?
https://www.cytodyn.com/investors/news-events...ab-pro-140
IV dosing:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2944554/
subcutaneous dosing:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2856743/
What changed in the understanding of half-life?
In any event, it makes good sense to go to IV and from 2 to 4 doses for critical Covid in CD16.
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