FDA grants Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 for the Treatment of Prostate Cancer
“Receiving the FDA’s RMAT designation underscores the critical unmet need in patients with early, localized prostate cancer and validates the promising clinical activity observed with CAN-2409. This designation further supports the design of our phase 3 study, including the DFS primary endpoint agreed upon with the FDA during the SPA negotiation,” stated Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel.
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