Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Here is my question, who's idea was it to test it on severe cases instead of sticking to mild & moderate??? Was this at the suggestion of the FDA????"

As I said, it doesn't matter....what's done is done and IPIX agreed to do it that way. But since you seem to think it's important, here's what I found (highlights added). Please take a few minutes to look at it:

On 10/2/20 a Company PR was issued to announce that it had submitted a meeting request to the FDA:
"In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis."

As you can see there's no mention of the patient group to be tested, but the PR did say......
"The request for the pre-IND meeting follows the FDA guidance issued in May 2020, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.”

That FDA Guidance document says this:

FDA recommends sponsors include the following content, and address the following issues, when developing pre-IND meeting requests that will support clinical development programs:
• Drug name.
• Description of the active ingredient, including its physical, chemical, and/or biological characteristics and its source (e.g., synthetic, fermentation, animal derived, plant derived,
biotechnology derived). For FDA-approved drugs, current labeling can address this request.
• Brief description of the manufacturing scheme for the active pharmaceutical ingredient and formulation for clinical study.
• The proposed indication (treatment, prevention, specific populations).
• Dosage form, dosing schedule, formulation, and route of administration.
• Known or suspected mechanism of action of the drug.
• Summary of the available pharmacokinetic information.
• Summary of the data and literature supporting the proposed use of the drug for treatment
or prevention of COVID-19.
• Summary of the available nonclinical pharmacology and toxicology data (see section
IV.C., General Nonclinical Considerations).
• Clinical information to support the proposed trial (see section IV.C., General Clinical
Considerations).

In order to get the meeting the Company had to announce the patient group it intended to test, and its intended dosages and the method of administration.
On 11/2/20 a new PR announced that "The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. The Company is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19."
No change/refinement in the patient description.

Several PRs later, on 12/21/20, a PR was issued that matter-of-factly announced that:
"The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-national, multi-center study expected to enroll approximately 120 patients with moderate-to-severe COVID-19.
(first mention)

So that's how the communication progressed. The Company could have included it in their proposal or the FDA could have recommended it in their feedback on the application or at the meeting itself. Either way the Company accepted it.

You posted that PR at 7:35AM on the Monday that it was issued. I just looked at the first 60 or 70 posts made after that and they expressed nothing but joy. There was nary a mention of the target patient group, just a bunch of attaboy Leo and off we go stuff.

I don't think anybody complained about it until about 11 months later.