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FDA Provides Positive Feedback on Tetra Bio-Pharma’s Application for ARDS-003 Clinical Development in COVID-19 Patients

April 5, 2021

Via: BioSpace

Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development is pleased to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the preclinical data package and clinical development plan of ARDS-003 to treat COVID-19 patients.

The review was conducted within the framework of the Coronavirus Treatment Acceleration Program (CTAP), the FDA’s expedited process for investigational therapies to treat COVID-19 patients. Overall, the FDA agreed with the animal toxicology and safety data to ensure that ARDS-003 is safe for human use, and approved the sample size, safety procedures and duration of treatment in severe COVID-19 patients.

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