FDA Grants the Pre-EUA Meeting Request by GoldenBiotech’s Applied Antroquinonol to Treat COVID
Exhibitor: GOLDEN BIOTECHNOLOGY CORP.
Booth No.: R309
The FDA Grants the Pre-EUA Meeting Date to GoldenBiotech’s Request for Antroquinonol to Treat COVID-19 Patients
Jul. 25, 2022
TAIPEI, Golden Biotechnology Corp. (GBC, GoldenBiotech, TPEx 4132), a leading Taiwanese biopharmaceutical company, announces that the FDA has granted GoldenBiotech's Pre-EUA (Emergency Use Authorization) meeting request for its investigational new drug (IND) Antroquinonol to treat COVID-19 patients.
The FDA refers to GBC’s correspondence on Jul.7 requesting a Pre-EUA meeting to obtain guidance on obtaining an Emergency Use Authorization application for the product for the treatment of COVID-19. Based on the statement of purpose, objectives, and proposed agenda, the FDA considered the meeting a type B meeting.
The FDA notices GoldenBiotech that the Pre-EUA meeting will be conducted by the Written Responses instead of physical meeting to be the most appropriate means for responding to the meeting request. Due to the unprecedented pandemic, the FDA is tentatively targeting its goal date for providing the written responses for September 9, 2022. Due to the current resources and workload capability of the FDA’s engagement in COVID-19 activities, there will be an additional notice if the date has changed.
Although the submission of the meeting package to the application is required by August 9, 2022, the FDA informs GoldenBiotech to provide as soon as possible for the review and response by the FDA.
The Pre-EUA meeting request is for the application with the results of the new drug Antroquinonol which completed the phase 2 clinical trial (IND149841) in the USA, Peru and Argentina, targeting to hospitalized patients with mild to moderate Covid-19 pneumonia.
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