Revive Therapeutics (RVV.V) is a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders. The company offers cannabinoid pharmaceutical portfolio that focuses on rare inflammatory diseases. It is developing Bucillamine, which is in Phase 3 clinical study for the treatment of infectious diseases, including influenza and COVID-19.
Today, the Company announced an update on the meeting written responses received by the Company from the U.S. Food & Drug Administration (FDA) of 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 FDA has determined that the Product should follow the De Novo regulatory pathway, and the Company would be required to conduct a clinical study for the De Novo submission for possible approval.
“We agree with the FDA feedback and with their recommendations that provides a pathway for the development of the Revive LC POC Lateral Flow Test Kit in the detection of long COVID,” said Michael Frank, CEO of Revive. “We will now discuss the proposed development plan and timelines with potential contract manufacturers.”
The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the Product as a potential blood biomarker diagnostic that characterizes long COVID. 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 (SARS-CoV-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 stock remains range bound. In recent days, the stock has tested the very lower limits of this range at $0.02. These levels are previous all time record lows for the stock. The stock needs to see a close back above the $0.025 level to get back within the range and eventually make a run towards the $0.04 zone.
