Variable | Launch delay | Review time | Submission delay |
|---|
| Ā | Without covariates | With covariates | Without covariates | With covariates | Without covariates | With covariates |
|---|
PR | 157.5 (587.5) | 513.3 (548.0) | 13.3 (133.8) | 75.7 (137.5) | 84.4 (552.0) | 499.5 (499.6) |
PR \(\times\) Post-PR | ā937.3 (615.7) | ā1157.0** (571.0) | ā130.9 (136.4) | ā175.0 (139.8) | ā795.9 (582.6) | ā1037.3** (520.8) |
Constant | 2135.2*** (452.8) | 6195.9 (88704.2) | 768.7*** (90.4) | 24280.7 (17645.5) | 1887.1*** (394.1) | 10836.8 (85327.1) |
N | 352 | 352 | 352 | 352 | 352 | 352 |
Adj-\({R}^{2}\) | 0.0625 | 0.2816 | 0.1947 | 0.3373 | 0.0483 | 0.2824 |
- Observations incorporated the post-PR approvals and the pre-PR approvals that were exclusively matched to either the real PR or the real non-PR. Robust standard errors were in parenthesis. Controls included were the FDAās designations of priority review, accelerated approval and orphan drug, the FDAās boxed warning at approval, the FDA review extension, the therapeutic areas [cancers, major infectious diseases (HIV/HCV), or others], the type of the pivotal trial enabling the NMPA approval (domestic trial, overseas trial, or global trial with sites in China), the approval class (NDA or BLA), the marketing class (initial marketing approval or new indication supplement), and the year of the NMPA approval. PR, priority review. NMPA, National Medical Product Administration. NDA, new drug application. BLA, biologics license application. *p < 0.10 **p < 0.05 ***p < 0.01.
