Innovation Pharmaceuticals Inc (IPIX)

[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.