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Re: Gohel Yoerselph post# 379457

Wednesday, 10/20/2021 1:54:08 PM

Wednesday, October 20, 2021 1:54:08 PM

Post# of 403043
I believe Leo would know if Innovation Pharmaceuticals was the sponsor of the Compassionate Use.
Innovation probably has sponsored some of the CU.

“The party who (1) submits a request to open an expanded access IND application and (2) receives FDA’s authorization to use the investigational product is considered the sponsor of the IND application. In the absence of any other sponsor (e.g. pharmaceutical company), the treating physician is the sponsor of the expanded access IND application.“

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-treatment-expanded-access-overview

IPIX received approval to sponsor CU patients from the FDA, the press release said so:

http://www.ipharminc.com/press-release/2021/9/23/innovation-pharmaceuticals-provides-update-on-covid-19-clinical-trial-compassionate-use-requests-and-research-into-brilacidins-broad-spectrum-antiviral-properties

“Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin.”
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