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petemantx

08/06/21 7:49 PM

#369258 RE: MaskedCat #369250

Those other 2 can give a much more reasoned reply than me.

My GUESS is the BP would cover the cost of the P3 and a P3 IS NOT essential to an EUA.

The definition of EUA includes the word 'Emergency' so why would it be an EUA if a successful P3 had already been conducted?

farrell90

08/06/21 8:24 PM

#369261 RE: MaskedCat #369250

Remdesivir was given an EUA at the interim report of its Phase 3 study. That's my best guess for Brilacin.

It could be sooner if the Phase 2 shows outstanding results, acing all the primary and secondary outcomes with absolute safety.

The other factor is the status of the pandemic. If the Delta virus outbreak continues to accelerate or if vaccine resistant or more deadly variants appear, Brilacidin could be pushed up to the drug of choice.

JMHO Farrell