Update
$Invivyd(IVVD.US$ Invivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of Symptomatic COVID-19, Based on Compact Clinical Programs to Establish Safety and Immunobridging for Serial Monoclonal Antibodies
• Newly outlined pathway provides a practical, expedient, repeatable immunobridging approach to potential emergency use authorization of serial, novel monoclonal antibodies (mAbs) to prevent and treat COVID-19
• Pathway provides for the establishment of a master, registrational clinical trial protocol that is anticipated to streamline the evaluation of new mAbs in compact clinical programs
• Utilizing this framework, Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311 that evaluates intravenous (IV) and potentially other routes of administration
• Newly outlined pathway provides a practical, expedient, repeatable immunobridging approach to potential emergency use authorization of serial, novel monoclonal antibodies (mAbs) to prevent and treat COVID-19
• Pathway provides for the establishment of a master, registrational clinical trial protocol that is anticipated to streamline the evaluation of new mAbs in compact clinical programs
• Utilizing this framework, Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311 that evaluates intravenous (IV) and potentially other routes of administration
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