The clinical trial of a cancer drug rejected by the Food and Drug Administration last week was marked by thousands of violations of study rules, damning investigator misconduct, and worrying signs of toxicity the company did not publicly disclose, according to hundreds of pages of internal documents obtained by STAT and confirmed by three people familiar with the matter.
Sesen Bio, a small biotech company that developed the bladder cancer drug, spent all of this year telling investors that its treatment was on its way to approval. After the FDA rejected it, CEO Thomas Cannell, fielding analyst questions on a Monday morning conference call, deemed it “a very surprising turn of events.”
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