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Re: Hugon post# 372173

Friday, 08/27/2021 10:28:40 AM

Friday, August 27, 2021 10:28:40 AM

Post# of 403046
Interesting, thanks. There was some chat about this last year:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159502368

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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