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IQ-AI Ltd on Tuesday said the US Food & Drug Administration has granted ’fast-track‘ designation for oral gallium maltolate, which is its subsidiary Imaging Biometrics LLC’s therapeutic for the treatment of adult patients with relapsed or refractory glioblastoma. The St Helier, Jersey-based medical services firm focused on cancer treatment said the FDA decision to grant fast-track status ’reflects the urgency and unmet medical need associated with GBM‘. ‘Receiving both fast-track and orphan drug designations from the FDA for oral GaM validates the importance of advancing the development of this treatment for these patients,’ IQ-AI said. Fast-track designation offers an accelerated review process with the FDA via increased communication and collaboration during the development process, IQ-AI said, with IB now ‘well positioned to utilize this streamlined and efficient process to bring this promising agent to the market as quickly as possible’. ‘This is an important milestone as well as a commercial accelerator, and we are firmly committed to working closely with the FDA to expedite the clinical development of oral GaM,’ said IQ-AI Chief Executive Officer Trevor Brown. Shares in IQ-AI were up 34% to 4.91 pence each in London on Tuesday afternoon. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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