SK Bioscience applies for rolling review of GBP510 in Britain
The rolling review enables the MHRA to begin an independent assessment of the vaccine using the results of Phase 1 and 2 clinical trials submitted by SK Bioscience. It reduces the time needed to get formal marketing authorization of the vaccine candidate.
The candidate is currently in global Phase 3 clinical trials. Marketing could begin in the first half.
Starting with the MHRA, SK Bioscience is planning to submit an application to European Medicines Agency, as well as apply for emergency use approval from World Health Organization in the first half.
BY SARAH CHEA [email@example.com]