Getting To A First Product Approval With Celcuity's Brian Sullivan

On this week's episode of the Business of Biotech, Brian Sullivan, CEO at Celcuity, talks about winning the company's first FDA approval for Revtorpyk, a kinase inhibitor for breast cancer patients, and why targeting an “untreated disease mechanism” can beat chasing a single mutation. Brian also discusses the process for licensing a shelved Pfizer asset for development, designing Phase 3 trials that challenge assumptions, the benefits of FDA's Real-Time Oncology Review, and managing downside risk while advancing new indications, all while building a launch-ready company without losing pipeline momentum.

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