Replies to post #369519 on Innovation Pharmaceuticals Inc (IPIX)

[LitesOut]

I believe there was an issue coming to an agreement with the FDA as to Phase III trial design and, by the time it was agreed, the stock had dropped enough to make it unfavorable to raise the funds required for a phase III. This was during a time at the FDA where they started wanting more fixed-dose trials for ease of evaluation rather than variable dosing based on weight. Keep in mind Brilacidin had always been dosed variably based on weight in all prior (and future) trials.

You can see this guidance (link below) posted December 2013 and the ABSSSI Phase 2B ended October of 2014. I know the FDA was pushing for fixed-dose Phase IIIs around this time, though that seemed to no longer be stressed after Margaret Hamburg left as FDA commish in 2015.

https://www.fda.gov/media/87621/download

Here's the quote from Page 24 where the FDA mentions fixed-dose trials are "generally preferred":
4.1 Fixed-Dose Clinical Trials
"A widely used trial design generally preferred for its ability to provide the clearest dose response data is the randomized, parallel group, fixed-dose, dose-response trial."

The pharmacokinetics of Brilacidin changes if you change the dosing regimen from weight-dependent to fixed, so using a single dose regardless of weight when that hadn't been evaluated before doesn't seem like the best design to use for a Phase III (at least without more data).