Blafarm, Unfortunately (or fortunately) the MM
Post# of 155485
(Total Views: 723)
Posted On: 06/22/2020 9:52:53 AM
Blafarm,
Unfortunately (or fortunately) the MM trial includes as Other Outcome Measures:
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 ]
This measurement where "crafted" by CYDY as Dr. Patterson mentioned in one of his presentations that the trial had been "exquisitely" (don't remember the exact world here but maybe it was this one or something for his effect) designed to give us a good reading of the effectiveness of Leronlimab.
And these readings are the one he is following and reporting in his paper. So, we will be well served by the other outcome measures in case these are needed as confirmation of the clinical outcomes.
If the primary outcomes show efficacy beyond doubt AND the other outcomes show numbers backing up the results the FDA will not have any option other than to approve (remember, this is just P2).
CRP would had been a nice addition in the primary outcome in lieu of myalgia as this latter is a bit unspecific and difficult to measure, also being less common in general (as compared to other symptoms) for COVID sufferers.
all imho.
Unfortunately (or fortunately) the MM trial includes as Other Outcome Measures:
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 ]
This measurement where "crafted" by CYDY as Dr. Patterson mentioned in one of his presentations that the trial had been "exquisitely" (don't remember the exact world here but maybe it was this one or something for his effect) designed to give us a good reading of the effectiveness of Leronlimab.
And these readings are the one he is following and reporting in his paper. So, we will be well served by the other outcome measures in case these are needed as confirmation of the clinical outcomes.
If the primary outcomes show efficacy beyond doubt AND the other outcomes show numbers backing up the results the FDA will not have any option other than to approve (remember, this is just P2).
CRP would had been a nice addition in the primary outcome in lieu of myalgia as this latter is a bit unspecific and difficult to measure, also being less common in general (as compared to other symptoms) for COVID sufferers.
all imho.
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