Noxopharm (ASX:NOX) today announces that on advice from the U.S. Food and Drug Administration (FDA), the Company has lodged a pre-Investigational New Drug (pre-IND) submission for a clinical trial of Veyonda® in patients with SARS-CoV-2 (COVID-19) infection. The submission is based on a response to a package submitted to the FDA summarising the rationale for conducting a clinical trial with an inhibitor of cGAS-STING signalling.
The urgency of the situation means that if the pre-IND is evaluated positively by the FDA, it can be converted into a fully expedited IND approval. The conversion of a pre-IND into a full IND is a new option offered to high priority COVID-submissions and reduces the time and complexity of the FDA review process significantly.
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