Posted by Michael Wonder on 23 Aug 2022
Veru granted expedited provisional registration regulatory pathway for sabizabulin treatment in hospitalised COVID-19 patients by Australia’s TGA
22 August 2022 - Veru today announced that Australia’s TGA has determined that sabizabulin treatment in hospitalised COVID-19 patients at high risk for acute respiratory distress syndrome qualifies for an expedited, provisional registration regulatory pathway.
A provisional registration determination by TGA is an expedited review of a provisional registration application, whose application, if authorised, would allow the drug to be prescribed in Australia earlier than the standard registration process.
