TBPMF - FDA gives positive feedback on Tetra Bio's ARDS-003 application in COVID-19

The FDA has favorably reviewed the preclinical data package and clinical development plan of Tetra Bio-Pharma's (TBPMF) ARDS-003 to treat COVID-19. The Agency 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.As a result of this feedback, the Company looks forward to filing an Investigational New Drug Application to initiate the clinical trial. The proposed study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome.Last month, Health Canada provided green light to Tetra Bio's ARDS-003 trial in COVID-19.

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FDA gives positive feedback on Tetra Bio's ARDS-003 application in COVID-19