Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

That's VERY clear. The trial protocol, first posted on March 5, said exactly as you quoted it:

The study will start with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing may be extended to 5 days.

I try not to argue with things that are as plain as the nose on one's face.
The question I have is whether the analysis referenced in the release of October 2 (5 months earlier) announcing the granting of a Pre-IND meeting...."Target enrollment is 120 patients, with a planned interim analysis."....is the safety data review that was completed in early April:
"WAKEFIELD, MA – April 5, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that an independent Data Monitoring Committee (DMC) completed its scheduled review of interim safety data"

And the reason for the question should be obvious.
There was no suggestion at all in the October release announcement of a "planned interim analysis" that the review to be conducted would be limited to safety or that it would be for the purpose of determining whether the initial dosage regimen could be extended. None. So I thought it a fair question.

But you're the Doctor and people are citing your opinion as gospel. (You are a Doctor, right?...I ask only because IPIX seems to be your only interest in this venue.) When you hear the phrase "planned interim analysis" in a press release and there is no mention of the term "safety", do you not expect efficacy to be part of such an analysis? I only ask because I do not know. If you have an example of where an established developer has done exactly that I'll accept it and be done with this.


All due respect,
Lots O. Noise



"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."