(CercleFinance.com) – Valneva announces that the US FDA has postponed, from the end of August to the end of November, its target date for completing the regulatory review of the marketing authorization application for VLA1553, its vaccine candidate against chikungunya.
The FDA wants to allow enough time for the parties to agree on the Phase 4 trial program required under the fast-track clearance process, but it has not requested any additional clinical data.
Valneva confirms that it plans for 2023 a possible approval of its marketing authorization application, the initial launch of the product and the potential award of a priority review voucher.
This postponement has no impact on its current regulatory submission in Canada, nor on a future regulatory submission to the European Medicines Agency.
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