Replies to post #360904 on Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

I hope you are right. I would be delighted if the Brilacidin for Covid 19 results are so positive it would get an immediate pass to an EUA.

Pfizer on the other hand may be hesitant to submit another drug for an early EUA after Merck's experience.

Merck partnered with Oncoimmune for their graft vs host drug for Covid 19 and surprisingly got rejected. Then,in spite of a good Covid 19 anti-inflammatory study; they pulled the drug.

Then you couple that with Cytodyn's experience it appears the FDA is becoming less welcoming.

GLTA,

Farrell

https://www.fiercebiotech.com/biotech/fda-tells-merck-told-to-show-more-data-for-its-oncoimmune-covid-drug-as-eua-pushed-back

https://www.merck.com/news/merck-to-discontinue-development-of-mk-7110-for-covid-19/

https://www.biospace.com/article/releases/oncoimmune-s-saccovid-cd24fc-exhibits-superb-therapeutic-efficacy-a-potential-breakthrough-in-treating-severe-and-critical-covid-19/

[steelyeye]

Brilacidin appears to tick all the boxes for an EUA application, and with moderately good results an EUA should a slam dunk.

Look at the FDA's 'Evidence of Efficacy' requirement and how it reads:

Quote: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

Innovation Pharma has now assembled:

1)Outstanding Pre-clinical in vitro data on more than one human cell line showing Brilacidin's abilities with C-19

2)Human safety information from more than one clinical trial.

3)A Peer Reviewed journal article based on Brilacidin's RBL results.

4)The current PH 2 clinical trial, which IMO is likely to be successful, is the final piece of information for the FDA to issue an EUA-- Efficacy!

[steelyeye]

Agreed, and thanks for spelling it out so clearly:

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.


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.

Someone should send CMC's entire post to Leo, although I suspect he is already on top of these important issues, time being of the essence with BP doing their own therapeutic trials.