Innovation Pharmaceuticals Inc (IPIX)

[thefamilyman]

That sounds reasonable. Unfortunately, I have no confidence that the FDA process for EUA will be reasonable. If they use an advisory committee to evaluate the EUA application, then there will probably well credentialed individuals on there who get major grants from competing Big Pharma (BP) companies. Amazingly, in the past, the FDA has not considered that a conflict of interest. But with all the current and future BP revenue at risk for other treatments and vaccines, they certainly have a reason to try to slow the approval of the EUA.

I would not be surprised if one or more foreign countries were the first to approve an EUA for Brilacidin. This might result in the US being at the back of the line for Brilacidin.

And there is no reason for how slow this process has been. Two independent Machine Learning studies had identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Besides that, the April 1, 2020 PR revealed that “ Brilacidin testing at a US Regional Biocontainment Laboratory resulted in a dose dependent reduction of Covid in viral teeters.” The “powers that be” certainly had multiple heads-up moments in that April - June timeframe in 2020.

Any legitimate evaluation of Brilacidin by people in authority following the release of those lab results back in June of 2020 should have resulted in an all hands on deck type response. Instead here we are 14 months later just wrapping up a Phase 2 human trial. Nearly 4,000,000 people have died since last June while people in authority twiddled their thumbs.

May 19, 2020 PR - …Brilacidin, in an in vitro experiment using VERO cells, reduced the viral titer (load) of SARS-CoV-2 by 75 percent after only 1 hour…

May 26, 2020 PR - In a human cell line, Brilacidin, in comparison to vehicle control, exhibited an inhibitory effect on SARS-CoV-2 in a dose-dependent manner—an average 29 percent inhibition at 0.1ug/ml (the lowest concentration) to an 85 percent inhibition at 100ug/ml (the highest concentration).

June 17, 2020 PR - Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested. Based on a CC50 value—the concentration of drug at which 50 percent of cells maintain viability—Brilacidin was also shown to be non-cytotoxic in the lung cell line.

CallMeCrazy said,

Leo should have the B-COVID FDA-EUA application already prepared, only needing P-2 results and his signature, and ready to deliver to the FDA for a process that appears to take from 6-8 weeks.