Imugene thrilled as VAXINIA granted FDA Fast Track designation
Melbourne, Victoria
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November 28, 2023 01:30 PM Eastern Standard Time
Imugene Ltd (ASX:IMU, OTC:IUGNF) CEO Leslie Chong and chief medical officer Dr Paul Woodard speak with Proactive following the news it’s been granted 'Fast Track' designation from the US Food and Drug Administration (FDA) for its MAST (metastatic advanced solid tumours) clinical program — evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA). The FDA’s Fast Track designation is awarded to help important new therapies reach patients earlier. It is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.
“The Fast Track process of drug development is designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need, with fast track status often leading to earlier drug approval and access by patients,” Chong said.
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