Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

For Covid pre-IND process from your download (FDA Covid PDF):

We recommend that sponsors seek initial advice under pre-IND meeting requests.5 For the purposes of our response to the COVID-19 public health emergency, we are consolidating the typical pre-IND meeting request and package development process into a single step. For preIND requests for drugs that treat or prevent COVID-19, the content requests and processes described within this guidance substitute for those used in other settings ...

The sponsor should submit a pre-IND meeting request in accordance with the process outlined in section V., Additional Resources, below. For both CDER and CBER, the sponsor should submit the meeting request with any specific questions to FDA. 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.

For those sponsors who already have an active IND for a drug in development, or have submitted a pre-IND meeting request or IND to FDA to investigate expanding the use of their FDAapproved drug for a non-COVID-19 indication, FDA recommends submitting a new pre-IND meeting request for a proposed COVID-19 indication, rather than amending their current submissions.

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FDA recommends sponsors include the following content, and address the following issues, when developing pre-IND meeting requests that will support clinical development programs:

• Drug name.

• Description of the active ingredient, including its physical, chemical, and/or biological characteristics and its source (e.g., synthetic, fermentation, animal derived, plant derived, biotechnology derived). For FDA-approved drugs, current labeling can address this request.

• Brief description of the manufacturing scheme for the active pharmaceutical ingredient and formulation for clinical study.

• The proposed indication (treatment, prevention, specific populations).

• Dosage form, dosing schedule, formulation, and route of administration.

• Known or suspected mechanism of action of the drug.

• Summary of the available pharmacokinetic information.

• Summary of the data and literature supporting the proposed use of the drug for treatment or prevention of COVID-19.

• Summary of the available nonclinical pharmacology and toxicology data (see section IV.C., General Nonclinical Considerations).

• Clinical information to support the proposed trial (see section IV.C., General Clinical Considerations).

I believe the briefing package occurs at the same time as pre-IND meeting request. I think we give them all the information above, they look it over, then have a pre-IND meeting to give further guidance on if that is a good way to go to submit the IND, or what else we will have to do to get the IND.

IND might not go in until November, with trial starting as soon as December? Will have to wait and find out how quickly they can get it done.