Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"I find it highly improbable, that the company in consult with the fda, via a pre-ind meeting, would design a P2 study for the treating of COVID-19 where the end data results in the inability to convey any statistical significance."

Okay, you find it highly improbable. I don't have any experience in clinical testing but I have a little practical knowledge of the effect of multiple variables on test results and a smidgen of common sense and I used those things to reach this conclusion:

"Maybe I underestimate the process, but it's hard for me to imagine that the results, if published, will distinguish between all of those variables and whether they will be able to convey any statistical significance."

I packed a lot into that sentence:
1. I may underestimate the process.

2. re: "the results, if published"
I probably should have said "when published". My understanding is that results must be published within a year for unapproved drug trials or within 30 days for those that are approved.
https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhenDoINeedToSubmitResults

3. re: "all of those variables"
60 patients will receive Brilacidin + a Standard of Care

There are 4 different categories with varying Standards of Care in the moderate-to-severe group being tested.
3 of the 4 categories include alternative treatments within the category.
I'm told that they also "can vary greatly from case to case and doctor to doctor".

Without reflecting that last open-ended doctor's option and assuming the variables are viewed equitably...almost certainly an unreasonable assumption...the vastly oversimplified math points to the following when the variables are applied:
15 patients in each category. (use 16)
8 alternate treatments, so 2 patients for every treatment.

So it's POSSIBLE that there will be 8 sets of patients, each including 2 who get B + (some) SOC and 2 who get Placebo + (presumably the same) SOC.

I hadn't done the math at the time, but that was the general consideration I had in mind when I wondered "whether they will be able to convey any statistical significance". For me the math confirms the validity of that question. For me.

I'm sure that the Company and the FDA did their own math and reached a different conclusion when they designed the trial, I just thought the point was worthy of some consideration before the results were published.

"Sounds like serious malpractice." I wouldn't and didn't suggest that. S___ happens:

201 trials analyzed.
The primary focus was to assess the effectiveness of existing therapeutic products against acute COVID-19 disease. In total, the trials involved 92 drugs as well as antibody-containing blood plasma, including 64 in monotherapy and 28 different combinations.
The researchers found that most of these trials demonstrated design weaknesses. For example, one-third of trials (67, 33.3%) lacked defined clinical endpoints (eg, discharge or survival); nearly half sought to enroll fewer than 100 patients while 54 (26.9%) fewer than 50 patients; about a quarter (49, 24.4%) did not have randomised design; and nearly half (97, 48.3%) were open label. Therefore, the authors said, many of these studies were “likely to yield only preliminary evidence of a given treatment’s safety and effectiveness against COVID-19.”
https://healthmanagement.org/c/hospital/news/design-flaws-of-covid-19-clinical-trials

Is the trial's goal "to yield only preliminary evidence of a Brilacidin’s safety and effectiveness against COVID-19"?