Wow indeed, just a little context for Dr Kelly's comments not appearing quite so abstract or detached from reality as you might suggest, even back in 2012 and earlier many approvals on single pivotal trials and "one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials" from 2005 to 2012.
"Approvals Based on a Single Trial
According to a 2014 JAMA study, between 2005 and 2012, FDA approved 188 novel therapeutic agents for 206 indications, and 74 indications (36.8%) were approved on the basis of a single pivotal trial. Most recently, IQVIA released a report finding that 25 of 59 (42%) novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. But as in previous years, a large portion of the drugs relying on only one trial were new orphan and cancer drugs.
For instance, AstraZeneca’s orphan drug Lumoxiti (moxetumomab pasudotox-tdfk) was approved in September 2018 based on one trial of less than 100 patients with a rare, slow-growing blood cancer. Stemline Therapeutics also won approval in December 2018 for Elzonris (tagraxofusp-erzx) to treat a rare, rapidly progressing cancer of the bone marrow and blood after conducting one trial of 94 patients in the US.Other cancer drugs, meanwhile, won approval after larger single trials."
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