(Total Views: 854)
Posted On: 11/10/2020 4:06:46 PM
Post# of 145247
![Avatar](https://investorshangout.com/images/ProfileImages/119774003_44865_IHub Pic.jpg)
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.
![78664965_pVLafterLeronlimab.jpg](https://investorshangout.com/images/MYImages/78664965_pVLafterLeronlimab.jpg)
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
![1601463993_IL-6AfterLeronlimab.jpg](https://investorshangout.com/images/MYImages/1601463993_IL-6AfterLeronlimab.jpg)
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.
![](/m/images/thumb-up.png)
![](/m/images/thumb-down.png)