Bringing a new treatment into clinical trials does generally need at least some OK preclinical (animal model) results, but it’s also as much a matter of money, politics and salesmanship. If you’ve got the money to carry out a trial, and acceptable preclinical data, then it’s not that hard to get the FDA to give you the go-ahead, as long as you’re not likely to make the patients sicker than they already are. And promising preclinical studies are a dime a dozen.
Okay.