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Regulatory Strategies to Employ When Your Study Doesn’t Qualify for Breakthrough/Prime

September 12, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

It is well understood that achieving Breakthrough or Prime Designation status provides sponsors with significant advantages in the regulatory process to achieve approval. However – not every drug candidate will qualify. This Forum will showcase best practice and real world examples of regulatory success, even without achieving coveted breakthrough status.