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Posted On: 08/12/2020 11:00:49 AM
Post# of 148878
SAF,
As far as I know we are the only drug right now with a double-blinded trial showing improvement for M-M.
And doing it in short time with a scientific moa backing it up.
PLEASE don't forge that there are measurements coming up !!!.
Other Outcome Measures:
The FDA will be faced with measurements of CD4 and CD8 and T cell counts progression for both cohorts.
Can they hide the comparison with placebo patients ???
I don't think so. As Dr. Patterson said: it works or it doesn't .
If demostrable counts don't move the FDA nothing will. Granted, they might say: I need more patients (and much more time). Fair enough, but it will be unconscionable with literally 1000's of people dying every day and Billions with B spent on economic slowdown.
FDA: do the right thing. Look at the numbers and approve for EUA or approve outright.
We are in a pandemic for Pete's sake !!!
As far as I know we are the only drug right now with a double-blinded trial showing improvement for M-M.
And doing it in short time with a scientific moa backing it up.
PLEASE don't forge that there are measurements coming up !!!.
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 FDA will be faced with measurements of CD4 and CD8 and T cell counts progression for both cohorts.
Can they hide the comparison with placebo patients ???
I don't think so. As Dr. Patterson said: it works or it doesn't .
If demostrable counts don't move the FDA nothing will. Granted, they might say: I need more patients (and much more time). Fair enough, but it will be unconscionable with literally 1000's of people dying every day and Billions with B spent on economic slowdown.
FDA: do the right thing. Look at the numbers and approve for EUA or approve outright.
We are in a pandemic for Pete's sake !!!
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