Breakthrough Therapy Designation application for oral gallium maltolate (GaM) in refractory brain tumors voluntarily withdrawn and resubmitted
“We view this feedback as an encouraging step forward,” said Trevor Brown, CEO of Imaging Biometrics Ltd. “We believe the FDA’s interest reinforces the scientific rationale behind GaM and supports our mission to accelerate new treatment options for patients facing devastating brain tumors. We are diligently working to incorporate additional biomarker and imaging efficacy data that will provide a more comprehensive picture of its therapeutic potential.”
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