Table 2.

Matched Comparison of Objections between ATMP and Biologicals Submissions

Evidence Domain	Differences in Objections between Successful ATMPs and Biologicals Submissions (n = 24)		Differences in Objections between Failed ATMPs and Biologicals Submissions (n = 10)
	Z	p (Two-Tailed)	Z	p (Two-Tailed)
Manufacturing and quality	−1.380	0.186	−0.674	0.625
Experimental design and conduct of the studies	−2.221	0.021∗	−0.674	0.625
Efficacy and MoA	−2.108	0.031∗	−0.137	1
Safety and toxicity	−0.431	0.727	−0.552	0.750
Total number of objections	−2.396	0.013∗	−0.674	0.625

∗p < 0.05. p values were determined by a Wilcoxon signed-rank test.