UK MHRA approval: Mail vom 09.02.: Valneva commenced rolling submission for initial approval of our inactivated COVID-19 vaccine candidate, VLA2001, with the UK Medicines and Healthcare products Regulatory Agency (MHRA) on 23 August 2021. We expect to submit the data from Cov-Compare to the MHRA as part of its rolling review, and we will continue to work very closely with them to complete that process. In the meantime, on 2 December 2021, the European Medicines Agency (EMA) announced that it started a rolling review of VLA2001. Valneva remains focused on achieving regulatory approvals of VLA2001 following positive Phase 3 trial results, announced on 18 October 2021, with potential regulatory approvals expected in the first quarter of 2022.
D.h. für mich dass noch keine weiteren Daten übermittelt wurden! " we expect..." |