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Posted On: 11/10/2020 4:06:46 PM
Post# of 148908
Dr. Patterson et-al paper is worth a fortune (literately) for those that can see and can read. I don't pretend to give advise to anybody, but, how much would you pay for a company that have a drug that can reduce viremia to undetectable levels, p=0.0012) and reduce IL-6 to normal levels, p=0.04 in 14 days??
And that, reported a decrease in expression of many IL-6 responsive genes, signaling repolarization of macropages ??
I just can't believe that FDA is not seriously looking at these results and then, looking at the NEWS-2 M/M and, then, looking at S/C interim is not seriously considering either an outright approval or an EUE.
As far as I am concerned, either I don't understand the meaning of these measurement, or I am too naïve to understand that the measurements don't mean anything without clinical outcomes (which, as far as I know, have occurred), or our regulatory institutions are willfully ignoring valuable evidence that can and could have saved lives.
I hope is my ignorance and nobody has blood on their hands.
Quote:
Following Leronlimab administration, SARS-CoV-2 plasma viremia decreased in all patients at day seven, and by day 14 all but one patient had resolved SARS-CoV-2 plasma viremia to undetectable levels p=0.0012.
Quote:
A reduction of plasma IL-6 was observed as early as three days
following Leronlimab and returned to healthy control levels by day 14
And that, reported a decrease in expression of many IL-6 responsive genes, signaling repolarization of macropages ??
I just can't believe that FDA is not seriously looking at these results and then, looking at the NEWS-2 M/M and, then, looking at S/C interim is not seriously considering either an outright approval or an EUE.
As far as I am concerned, either I don't understand the meaning of these measurement, or I am too naïve to understand that the measurements don't mean anything without clinical outcomes (which, as far as I know, have occurred), or our regulatory institutions are willfully ignoring valuable evidence that can and could have saved lives.
I hope is my ignorance and nobody has blood on their hands.
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