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thefamilyman

10/17/21 11:50 AM

#379047 RE: petemantx #379043

I agree. I was subtly trying to make this exact point.

Petemantx said,

Think this is a "non-problem".

sunspotter

10/17/21 12:28 PM

#379054 RE: petemantx #379043

This may surprise some, but the ultimate responsibility for all aspects of any medicine rests with the Marketing Authorisation applier or holder.

At the very least that means the ability to comprehensively audit every part of the process from research to distribution, even if every part of it is sub-contracted out.

That requires a surprisingly large internal quality department, which by definition IPIX does not have.

In the totally hypothetical circumstance that brilacidin proves safe and effective in COVID-19, then there is not a single scintilla of doubt that they will need to partner with a company that does have these capabilities.

To set it up from scratch would take a years or more for validation alone.