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Re: loanranger post# 325988

Thursday, 10/01/2020 2:10:41 PM

Thursday, October 01, 2020 2:10:41 PM

Post# of 403545
This is what I was alluding to yesterday, and I believe the answer to be 'yes'.

I don't know the concentrations from the ABSSI P1 dosing and we don't have concrete info from the C19 IC50/90, but I believe the data to be sufficient with additional input from the GMU RBL, to not require further animal-testing. My understanding is they're (RBL) working with IPIX to sort dosing data for the IND.

But be plain for me:
Are you saying that the safety determinations, whatever they were, in the Cellceutix B-Acute Bacterial Skin and Skin Structure Infections IV Phase 2 trial, will be adequate to determine the safety of B-Coronavirus to the satisfaction of the FDA, allowing a Phase 2 trial to proceed without animal trials?

(I did my best to get that down to a yes or no question, also avoiding the question of whether the portion of your 500 doses that obviously involved swishin', squirtin', pill swallowin' and the Polymedix trial could be used as supporting evidence.)

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