Wednesday, October 20, 2021 1:54:08 PM
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.”
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
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