Replies to post #355260 on Innovation Pharmaceuticals Inc (IPIX)

[FatAlbert1986]

That’s what I’m getting from the clear statement as well. I think the agenda was to make people doubt Leo if he doesn’t update on efficacy in the interim. This way we take no news as bad news. I’m just trying to make sure that everyone understands what the talking points are. The goal is for you to think this is a gamble, IPIX cannot succeed because of big Ol’ Pharma, a corrupt government, its agencies and of course, Leo’s sly ways.

[frenchbroad]

*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.
That's pretty clear.*
Sure not for some who want to say Ipix and M Ehrlich lie and are criminal.

[Justfactsmam]

Biodoc…. YOU are right on…END OF STORY…

"Interim analysis":
From the trial protocol:

Quote:
________________________________________
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.
________________________________________

That's pretty clear.

https://clinicaltrials.gov/ct2/show/NCT04784897?term=brilacidin&draw=2&rank=2

This line of esoteric questioning of what “it” is…is a total witch hunt and immaterial. The “interim analysis” review is specifically addressed in the CLINICAL TRIAL PROTOCOL DICTATED BY THE FDA …

It is totally futile line of questioning since the FDA defined and dictated the Interim Analysis was a “safety” review and with a short trial of 120 patient trial, the trial would be over before efficacy interim analysis could be completed…therefore it is perfect sense that "Interim Analysis" is what the FDA has defined it... for “Safety”.

LEO will not give those disparaging IPIX or HIM anything to work with.

IMO..IPIX will reach Clinical Trials fulfillment in full compliance of FDA/RUSSIAN FEDERATION rules, regulations and dictated protocol… minimal statements by LEO in PRs will be made to avoid these exercises.

[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."