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Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDAThe submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an Emergency Use Authorization for a PCR-based IVD for COIVD-19 detectionGlobeNewswireApril 02, 2020Ann Arbor, Mich., USA, April 02, 2020 (GLOBE NEWSWIRE) -- In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients.
Source: AsiaOne