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frrol

12/15/18 10:30 AM

#251400 RE: slcimmuno #251397

More accurately: Adhere to the prescribed protocols and get satisfactory efficacy and safety results...

TheDane

12/15/18 11:20 AM

#251401 RE: slcimmuno #251397

Like minds. I posted the same quote the other day...it seems Yuge-ly significant for IPIX and probable partner possibilities...

Agreements reached at the meeting on these matters will be recorded in minutes of the conference that will be taken by FDA in accordance with 10.65 and provided to the sponsor. The minutes along with any other written material provided to the sponsor will serve as a permanent record of any agreements reached. Barring a significant scientific development that requires otherwise, studies conducted in accordance with the agreement shall be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval for the drug.”

PlentyParanoid

12/15/18 1:08 PM

#251405 RE: slcimmuno #251397

Thanks slcimmuno. I always appreciate your contributions.

I did the latest comparison mostly to see how brilacidin vs dusquetide looks and came to conclusion which is probably best stated using terminology made famous by Donald Rumsfeld.

"Based on dusquetide's approval for phase 3 in SOM and our current knowledge about Brilacidin vs dusquetide, brilacidin should also obtain phase 3 go ahead unless there are Brilacidin related negative known or unknown unknowns."