FDA Accepts NDA for Gedatolisib in HR+/HER2-/PIK3CA WT Advanced Breast Cancer
“The FDA’s acceptance of our New Drug Application for gedatolisib and the assignment of a PDUFA goal date is a pivotal milestone in our efforts to bring a much-needed new treatment option to patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “We believe the robust clinical dataset underlying this submission demonstrates the practice changing potential of gedatolisib. We are looking forward to collaborating with the FDA throughout the review process as we work towards a potential approval and commercial launch.”
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