Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

That was an interim analysis that sounded very good at the time. Unfortunately upon the completion of the "Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections" the company decided that there should be "No Study Results Posted on ClinicalTrials.gov for this Study".
https://clinicaltrials.gov/ct2/show/results/NCT02052388?term=brilacidin&draw=2&rank=2

The current 10K says this:
"ABSSSI — In February 2016, the Company submitted a Special Protocol Assessment (SPA) request, along with a final protocol, to the FDA, for a Phase 3 clinical trial of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). We received from the FDA comments and considerations for incorporation into our study design."
https://www.sec.gov/Archives/edgar/data/1355250/000147793220005387/ipix_10k.htm

The FDA comments and considerations for incorporation into the study design weren't released.


A more detailed discussion of B-ABSSSI is in the 10K issued after the trial was completed (year ended 6/30/15) can be found on p.7-8 at https://www.sec.gov/Archives/edgar/data/1355250/000147793216012448/ctix_10k.htm.
It includes the same language:
"We have received from the FDA comments and considerations for incorporation into our study design."



Were any of those comments related to safety? Did the FDA make comments about the proposed dosages?
As I understand it an acceptance of the SPA study design by the FDA would have allowed the Company to anticipate an approval as long as the Company stuck to that design and met the desired outcomes.