Keep in mind Fluvo was / is already FDA approved for OCD with only know side effect nausea. It’s an oral too. Everyone read the article. Lotta pressure on Ipix to deliver excellent results and then either cash in on those or go massive to a massive ph3 with the government in one of these lottery gun slinging 8-10 arm adaptive trials.
Your point about the hurdles ahead for brilacidin's approval is spot on.
Unless brilacidin literally raises the dead, there's no way they'll get even an EUA based on a 120 patient Phase II, assuming the trial succeeds in showing brilacidin is safe and effective in COVID-19*.
And it's not only the large Phase III that will be needed - as loanranger has highlighted in his normal elegant and erudite style, FDA will want guarantees about continuity and security of supply which I suspect IPIX are ill-prepared to be able to satisfy:
"The numbers are thoroughly redacted but the FDA made a concerted effort to secure the data needed (inventory, production capacity, dosages) to assure that supply of Baricitinib was or could be adequate. Again as you might expect (and I fail to grasp) the issue of adequate remdesivir wasn't mentioned. It will be interesting to see what IPIX has for supply support should an application be submitted."
Sounds like Leo should be talking to these guys...
TOGETHER is funded by private philanthropists, including Fast Grants, an initiative by Silicon Valley billionaire Patrick Collison and economist Tyler Cowen to speed pandemic response by getting grant money out rapidly.
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