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Comparison of the Regulatory Actions for Applications That Did and Did Not Have Prior Expanded Access Experience.a
| Regulatory Action | No Expanded Access, n (%) | Expanded Access, n (%) |
|---|---|---|
| Approved | 175 (76) | 76 (84) |
| Refuse to file | 9 (4) | 9 (10) |
| Complete response | 47 (20) | 6 (7) |
Nominal P = .001.
