Revive Therapeutics announces FDA acceptance of meeting request

Revive Therapeutics announced that the U.S. Food & Drug Administration has accepted the Company’s meeting request for the Revive LC POC Lateral Flow Test Kit for feedback on the classification, development and regulatory submission strategy for a point-of-care in vitro diagnostic device that aids in the detection of post COVID-19 conditions. The meeting date assigned by the FDA is June 7, 2024. The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the Product as a potential blood biomarker diagnostic that characterizes long COVID. The discovery of the biomarkers identified by a research team at Lawson, led by Dr. Douglas Fraser, was recently published in the journal, Molecular Medicine. Currently, there is no FDA-approved clinical diagnosis of long COVID and it is estimated to occur in at least 10% of severe acute respiratory syndrome coronavirus 2 infections. More than 200 symptoms have been identified with impacts on multiple organ systems – including fatigue, brain fog, difficulty breathing, and cardiovascular symptoms ranging from chest pain and arrhythmias to sudden cardiac death – but it remains a diagnosis of exclusion with an unknown biological basis. The Company entered into a license agreement with Lawson Health Research Institute for the worldwide exclusive rights to the intellectual property of novel blood biomarkers that characterize long COVID. The intellectual property includes PCT/CA2023/050145 entitled “Blood Biomarkers in Long-COVID19”; PCT/CA2023/051292 entitled “Biomarkers in Long-COVID19”; and US Provisional Patent Application No. 63/433,425 entitled “Diagnosis and Treatment of Long-COVID”.