Question: 6. A drug developer is considering requesting Breakthrough Therapy status of their investigational drug rather than following the traditional clinical development pathway. What are the

6. A drug developer is considering requesting

6. A drug developer is considering requesting Breakthrough Therapy status of their investigational drug rather than following the traditional clinical development pathway. What are the biggest differences between these two pathways? A. Amount of data submitted to the FDA for review B. Amount of guidance provided by the FDA during development C. Amount of time the FDA requires to review the application D. Endpoint used in the phase 3 clinical trial E. Post-marketing study requirements

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