Innovation Pharmaceuticals Inc (IPIX)

[wsbc]

I'd be surprised if we don't see an EUA (Emergency Use Authorization) applied-for following the interim analysis, personally.

- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/summary-process-eua-issuance

-https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-declaration

-**https://www.federalregister.gov/documents/2020/09/11/2020-20041/authorizations-and-revocation-of-emergency-use-of-drugs-during-the-covid-19-pandemic-availability **

interesting info on HCQ and the rejection notice, along with examples of approvals and material referenced in the last link.

I feel like given positive interim results for B as a single-dose IV administered drug, going to BARDA + FDA for an EUA approval would make sense. BARDA for funds to ramp production immediately and on a massive scale, and to concurrently run treatment + a P3 possibly for C19. I'd also be looking for a massive partnership at that time. In lieu of a partnership, CTAP could prove useful for distribution management, but only domestically. Partnership would be useful worldwide.

The PR explicitly mentions the use of "planned interim analysis".
According to
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/
Quote:
Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success.

This indicates to me that Leo might be planning to use the interim data to quickly escalate the study to phase 3.