FluoGuide announces regulatory approval from Swedish Authorities (MPA and Ethics committee) to commence Phase II clinical trial with FG001 in guiding surgery of high grade glioma in Sweden
Copenhagen, Denmark, 26 August 2021 – FluoGuide A/S (“FluoGuide” or “the Company”) is pleased to announce that the company has received regulatory approval for expanding the ongoing clinical phase I/II trial to Sweden with FG001.The ongoing clinical phase I/II trial with FG001 is designed as a two-phased trial, where the first phase aims to identify the optimal dose and investigate safety and tolerability. Phase II will provide efficacy data that will be used to design the following pivotal phase III trial intended to support regulatory approval of FG001 in high grade glioma, aggressive