HISTORICALLY, FAILED ANIMAL DRUG STUDIES LED TO A NO-GO. And equally, if a drug passed the animal study hurdle it usually progressed to human studies. Of those, a high percentage failed. Those drugs that got approved were successful in both animal models and in human trials, showing concordance. But it is fair to ask whether an early No-Go based on a failed animal study was meaningful. Animal models have been under criticism for poor predictability. It is likely that patient-derived tissues may improve the predictability rate of preclinical studies, but tissues are still not whole organisms.
http://www.nature.com/nm/journal/v19/n4/full/nm.3163.html