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It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake
\n\n\n\n It is critical to note, however, that preclinical safety data no matter how consistently positive cannot be directly extrapolated to humans without proper clinical trials
[DOI] [PMC free article] [PubMed] [Google Scholar] 63.Ekstedt M., Franzn L.E., Mathiesen U.L., Thorelius L., Holmqvist M., Bodemar G., Kechagias S