Replies to post #336083 on Innovation Pharmaceuticals Inc (IPIX)

[crashco]

Thank you for posting the article. The closer we come to putting Brilacidin to the ultimate test the more difficult it becomes to remain patient and calm. The fact that an additional manufacture has identified Brilacidin as a worthy candidate for production proof-of-concept studies (and investment of resources), and, further still, is willing to cite those activities as an example of their preparedness for rapid manufacturing ramp up is encouraging.
GLTALs. Go IPIX. Get the trials underway.

[multiples]

Great find. The timing of this article is fascinating.

[thefamilyman]

It certainly sounds like Seqens has made a fairly significant investment in developing a more efficient and cost effective process for making Brilacidin. Makes you wonder why? There is currently no significant market for Brilacidin so what motivated Seqens? Could it be that there is more going on behind the scenes than we know?

SitTight said,

Just FYI: interesting new case study regarding the production of Brilacidin.

The Importance of a Global Leader in Small Molecule Manufacturing During the COVID-19 Pandemic
https://www.pharmasalmanac.com/articles/the-importance-of-a-global-leader-in-small-molecule-manufacturing-during-the-covid-19-pandemic

Of course, IPIX's Brilacidin supplier is Evonik and not Seqens. But they seem eager and have an interesting approach to produce Brilacidin more efficiently.

[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

[PJ007]

Great find!!!!!

[cabel]

Why is your link no longer there,...?

[Empiricst1]

Nice catch, great dd.