“Fast Track designation for FG001 is a meaningful recognition by FDA of the significant unmet need in high-grade glioma and the potential of our program to improve intraoperative tumor detection,” says Donna Haire, COO of FluoGuide “We greatly value the opportunity to work closely with the FDA and deeply appreciate their engagement as we continue to advance FG001 for patients facing this devastating cancer.”

Following the FDA green light on FluoGuide’s IND in January, the company is in preparation to initiate the planned U.S. Phase 2 registration trial of FG001 in high-grade glioma with first patient planned to be enrolled in Q2 this year. FluoGuide anticipates that two U.S. clinical trials will be required to support U.S. regulatory approval of FG001 for HGG.

“We are very pleased achieving this important milestone in our endevor to help patients with high-grade glioma” says Morten Albrechtsen, CEO of FluoGuide.