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. 2013 Nov 15;8:179. doi: 10.1186/1750-1172-8-179

Table 4.

Multivariate relative risks of an application for an orphan designation at EMA or FDA

Variable Univariate RR (95% CI) Multivariate RR (95% CI)
Prevalence
 
 
1-9/1.000.000
5.0 (2.7–9.2)
2.8 (1.4–5.4)
<1/1.000.000
Ref
Ref
Preclinical proof of concept?
 
 
Yes
6.0 (3.0–12.0)
3.9 (1.9–8.3)
No Ref Ref