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Re: loanranger post# 371476

Monday, 08/23/2021 3:28:04 AM

Monday, August 23, 2021 3:28:04 AM

Post# of 403061
"This was:
"a B/R combo drug”
versus
"alongside remdesivir, not for an infusion bag containing both drugs".....which I don't think I said.
"

If you can think of some other way of having a combination drug consisting of brilacidin and remdesivir, please let me know:

"a combination drug or a fixed-dose combination (FDC) is a medicine that includes two or more active ingredients combined in a single dosage form."

https://en.wikipedia.org/wiki/Combination_drug

That would indeed take a long time to develop and would require input from Gilead not to mention a new clinical trial and CMC program.

Fortunately that wouldn't be required in the hyopthetical circumstance of blow-out results from the brilacidin C19 trial.

IPIX could apply for EUA of brilacidin alongside SOC without input from any of the manufacturers of SOC drugs such as remdesivir or dexamethasone.

Such approvals are commonplace as NDAs and no reason why that wouldn't work for EUAs as well.


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