Replies to post #322357 on Innovation Pharmaceuticals Inc (IPIX)

[roiresearch]

Pinksheet stocks are a tough sell, but not impossible. IPIX doesn't have a rosy past of being able to execute. The amount of news that has come out compared to the PPS says the market doesn't really believe in B for C. I think once the FDA gets involved and not a variety of unnamed labs (RBL, PHRI, University) then the PPS goes on to make new heights. Maybe the unveiling of all the labs involved when the preprint is made available will have a positive impact on price along with confirmation of data investors have seen to date via vague PR's.

Trying to rationalize why there was no PR stating the RBL is done. Was testing delayed? Is testing done? Was it determined additional data was needed? I am not a long time investor here but it is clear the ceo is not one to disclose 'not so great info.' Is everything happening so slow? Is everything happening so fast that it's best to collect all the pieces before issuing the next PR for the best impact? Are we waiting for pre-print before issuing next PR to avoid the doubting Thomas?

IPIX will have it's day in the sun (or more likely a good run). We are all being exhausted by the dwindling pps yet amazing potential. i chose to pre-occupy myself so as not to watch tick by tick possibly 2nd guessing my decision to believe in B for C as well as the pipeline. TIme will tell. In a month i am happy to say i was wrong.

[To infinity and beyond!]

That is what is difficult now about IP. June 17 shout out to the world has not yielded anything but potential- no grant, no partnership.

All those Sept catalysts are events only and will not budge share price unless there is a very big grant announced

It is going to be a very long fall and winter here frankly-

[loanranger]

"September catalysts:
CTAP update
IND confirmation; human trial start date"

Coronavirus Treatment Acceleration Program (CTAP) Frequently Asked Questions
Q. How can I maximize my chances of starting a trial for my investigational therapy for COVID-19 as quickly as possible?

By presenting a strong scientific rationale and supporting data showing that the therapy is appropriately safe to enter clinical trials and has the potential to be effective in patients.
Start by taking full advantage of our pre-IND program. We have found that a complete pre-IND submission is the key to expediting comprehensive pre-IND advice, more rapid review of the subsequent IND and more rapid clinical trial initiation. Guidance regarding pre-IND meeting request content for COVID-19 drugs or biological products is at: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 related Drugs and Biological Products.
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap-frequently-asked-questions


The pre-IND program program starts with submitting a Pre-IND meeting request, presumably followed by a meeting.
"The pre-IND meeting request will be reviewed and generally responded to as a written response only meeting.
7 FDA’s review and advice for the pre-IND meeting request will be expedited and prioritized based upon the completeness of the submission and scientific merit.8 Following review of the pre-IND meeting request, FDA will work with the sponsor to help ensure that all necessary information has been submitted. This pre-IND review will help result in a more efficient review of the subsequent IND submission."

Additional Recommendations for Antiviral Drugs
"Investigational antiviral drugs can be identified based on cell culture antiviral activity data (i.e., half maximal effective concentration (EC50) value and therapeutic index) and, preferably, on animal model findings, but these activity data may not reliably predict benefit in human patients. Following characterization of the safety profile of the drug in toxicology and pharmacology studies and early stage clinical trials, the sponsor will need to establish the effectiveness of the drug."
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-public-health-emergency-general-considerations-pre-ind-meeting-requests-covid-19-related

Then comes the IND submission itself.

"Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved."
https://en.wikipedia.org/wiki/Investigational_New_Drug



What does all of that mean in terms of your September Catalyst expectations?
CTAP update: What is that exactly?

IND confirmation: Are you saying that you expect the Company to make its IND submission during September?

human trial start date: Are you expecting to know when human (aka clinical) trials will begin during the month of September?
Is it your understanding that they can begin 30 days after the IND submission is made assuming the FDA doesn't object and put any trials on hold?



The process is hard to follow (of course it is....it's gov't stuff). Dividing it into its steps is a good idea but they need to be defined well enough so that, if a person was brave enough to try to create an anticipated chronology, it could be followed.

I couldn't get past your first two catalysts without wondering what CTAP updates and IND confirmations are.

Of course I may be the only one who doesn't understand, but if that is the case please humor me with an explanation.