09:55 AM EST - BioVaxys Technology Corp. : Announced today that it is has filed a pre-IND (Investigational New Drug) meeting request and submitted a briefing package with the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) for Covid-T, its T-cell immune response diagnostic for SARS-CoV-2. The pre-IND meeting is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, and quality control. BioVaxys anticipates a written response to its pre-IND briefing package later this month. BioVaxys Technology Corp.
shares C.BIOV are trading down 1 cent at $0.37.
