Table 3.
Milestone Timing and Variance.
| Review Milestone | Median Time, Calendar Days | 5th Percentile, Calendar Days | 95th Percentile, Calendar Days |
|---|---|---|---|
| Receipt of dossier to Start primary assessment (84) | 214 | 28 | 989 |
| Agency time 1st cycle Primary scientific assessment to Primary outcome letter (84) | 19 | 3 | 168 |
| Approved products 1st Cycle Primary outcome letter to MAA (4) | 15 | 8 | 42 |
| 1st Cycle primary outcome letter to Company response (80) | 120 | 21 | 236 |
| Agency time 2nd Cycle Company response to 2nd cycle outcome letter (80) | 43 | 13 | 141 |
| 2nd Cycle Response to MAA for those approved (21) | 13 | 6 | 42 |
| Company time 2nd cycle 2nd cycle outcome letter sent to Company response (59) | 98 | 7 | 125 |
| Agency time 3rd cycle Company response to 3rd cycle outcome letter (59) | 36 | 5 | 114 |
| 3rd Cycle outcome letter to MAA for those approved (45) | 13 | 6 | 32 |
| Company time 3rd cycle outcome letter sent to Company response (14) | 86 | 8 | 127 |
| Agency time fourth cycle Company response to fourth outcome letter (14) | 26 | 7 | 67 |
| 4th outcome letter to MAA for those approved (14) | 19 | 6 | 49 |
MAA marketing authorisation application.