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Sunday, February 28, 2021 9:17:54 AM
It's probably not important, but my objection was to your statement:
"if I recall correctly from one of the PRs, or investor updates, the B trial adds B or placebo to the standard of care, Remdesivir plus steroids."
It may be reasonable to conclude that...it may even be common knowledge....but I found nothing in the IPIX PRs or investor updates that described "Remdesivir plus steroids" as the Standard Of Care.
Moving on....
The most recent PR describes the trial this way:
"The Phase 2 Brilacidin for COVID-19 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19."
· Active Arm (Brilacidin): Standard of Care + daily Brilacidin IV infusion for 3 days
· Control Arm (Placebo): Standard of Care + daily Saline IV infusion for 3 days
The NIH has a website on "Therapeutic Management of Adults With COVID-19 (Last Updated: February 11, 2021)" and a Table that describes the COVID-19 Treatment Guidelines Panel's recommendations based on disease severity. It doesn't copy and paste but hopefully the image is readable:
![](http://investorshub.advfn.com/uimage/uploads/2021/2/28/orfxscovid_gl_figure3.jpg)
The "Hospitalized, requiring supplemental oxygen" and "Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care" sections comprise the moderate severity subgroups. The two bottom profiles are considered severe.
Naturally the Panel's recommendations vary for each of the 4 profiles so the Standards of Care vary accordingly and you acknowledged that here:
https://investorshub.advfn.com/boards/replies.aspx?msg=162200793
It seems to me that the 120 subject population (60 of which will get Brilacidin) is a pretty small sample size when one considers that there are 2 study arms, 4 different categories of treatments based on severity and Standards of Care which, as you say, "can vary greatly from case to case and doctor to doctor".
Maybe I underestimate the process, but it's hard for me to imagine that the results, if published, will distinguish between all of those variables and whether they will be able to convey any statistical significance.
I guess it's best just to wait and see.
“I have had a wonderful time but this wasn't it.”
..........Groucho
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