Replies to post #360723 on Innovation Pharmaceuticals Inc (IPIX)

[Lemoncat]

Farrell,

What sort of revenue do you think can be generated with expanded compassionate use? Do you think it is enough to put a dent in the phase 3 trial and alleviate some of the financing pressure until we get EUA? Or is it negligible?

Go IPIX!

[steelyeye]

Stickie worthy post as to timelines, depending on PH 2 results.

Wish I had some coins to drop on this post.

[CallMeCrazy]

I disagree.

'farrell90' said:

If the phase 2 Brilacidin trial is very positive. I believe expanded compassionate use could be begin soon. To be quickly followed by an announcement of a phase 3 study with grants and possible partnership. If the phase 3 study shows promise at the first interim report we could see an EUA. Formal FDA approval would be given after the phase 3 trial is completed.

IMO, Leo should already have the EUA prepared, awaiting phase 2 results (whatever they are) for inclusion in the application. The goal here is to make the EUA COVID treatment billion$ in the same way Pfizer made dozens of billion$ on their EUA vaccine, mainly by creating the first effective and approved vaccine.

IPIX doesn't need to waste precious time doing a phase 3. Look at the FDA's 'Evidence of Efficacy' requirement and how it reads:

Evidence of Effectiveness

Medical products that may be considered for an EUA are those that "may be effective" to prevent, diagnose, or treat serious or life-threatening diseases or conditions...

The "may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals.2

In determining whether the known and potential benefits of the product outweigh the known and potential risks, FDA intends to look at the totality of the scientific evidence to make an overall
risk-benefit determination. Such evidence, which could arise from a variety of sources, may include (but is not limited to): results of domestic and foreign clinical trials, in vivo efficacy data from animal models, and in vitro data, available for FDA consideration.


Unapproved Products

The range of available data for unapproved products will differ widely. FDA recommends that any request for consideration for an EUA include available preclinical testing data, such as in-vitro and animal toxicology data. FDA also encourages that human safety information from clinical trials and individual patient experience be provided, if available. Data submitted in the request should attempt to link the likely exposure to the MCM to any relevant, existing preclinical data. Similarly, when animal data are used, sufficient information should be provided to link the results of these data to expected exposures to the MCMs related to the proposed use in humans. Any information on safety associated with use in humans of this or related compounds or devices of a similar design should also be submitted.

https://www.fda.gov/media/97321/download

Brilacidin can meet these standards and go on to earn an EUA with the U.S. Government as a probable first contract worth hundreds of millions, if not billions.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163549419

This is a time for business development not pipeline development. Leo should be lining-up manufacturing capacity so that when the EUA is issued IPIX can start writing and filling contracts, all the while trying to secure EUAs in as many countries as possible. There are billions of dollars to be made with an EUA for COVID treatment, provided IPIX is among the first few to get it.

Big Pharma understands the need for speed and this explains why Pfizer began a phase 1 study of a protease inhibitor for COVID treatment in March 2021 and expects to have it available in oral form by end-of year 2021. That's "warp speed" fast.
https://www.cnbc.com/2021/04/27/pfizer-at-home-covid-pill-could-be-available-by-year-end-ceo-albert-bourla-says.html

But orally isn't the only way Pfizer wants to treat COVID:

Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, which is currently in a Phase 1b multi-dose trial in hospitalized clinical trial participants with COVID-19.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-phase-1-study-novel-oral-antiviral#:~:text=Footer%20Aside%20Section1-,Pfizer%20Initiates%20Phase%201%20Study%20of%20Novel%20Oral,Agent%20Against%20SARS%2DCoV%2D2

Apparently, Pfizer plan to file for a EUA after only a phase 1. But why not? There's no EUA requirement for any particular phase of clinical trials to be completed. Pfizer and other BP are trying desperately to cash in on the lower efficacy standard for a EUA. Lower standards, quicker cash This is what IPIX should be doing.

IMO, IPIX doesn't need grant money or a phase 3. IPIX needs a business strategy involving partnering with manufacturing entities and others to build a global portfolio of EUAs for B-COVID in order to maximize global profits.