Regardless of what you want to call it, whether it’s expedited review or special protocols, limited use medicines, the theory is, “How can the FDA help bring important therapies to the market faster?” And, there are a lot of pieces to that puzzle.
At the end of the day, the agency still has to meet with the sponsor, who still has to have data. They have to meet and decide how to move forward.
There are two issues that also have to come into this conversation:
- The patient voice
- Benefit / risk profile