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Friday, August 27, 2021 10:28:40 AM
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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."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165571654
*I don't think it will, for several reasons I have discussed in other posts.
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