Innovation Pharmaceuticals Inc (IPIX)

[sunspotter]

That's a good find- well done.

While it's encouraging that this work has been done, it does suggest that a lot of CMC (Chemistry, Manufacturing and Controls) work needs to be done before brilacidin can be marketed on the scale necessary should it prove to be safe and effective in treating COVID 19.

With the requirements for scale-up, validation, stability, identification and quantification of degradation products and associated toxicology studies of any degradation products it would be unrealistic to expect the product could be ready for marketing in less than a year.

There's a useful simple guide to the IND and NDA process here which covers some of the requirements for CMC and other areas here:

https://www.fda.gov/media/91746/download