Sesen Bio's Bladder Cancer Trial Wrecked By Misconduct: Stat News
- Sesen Bio Inc (NASDAQ: SESN) said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum.
- But the rejected filing includes several violations and investigator misconduct, STAT News reported.
- Related: Sesen Bio Stock Crashes As FDA Shoots Down Its Bladder Cancer Pitch.
- The 130-patient study had more than 2,000 violations, 215 classified as major, STAT reported.
- Independent monitors also reported three investigators to the FDA for a “serious noncompliance” that “placed subjects at risk of harm.”
- A patient died in 2016 of liver failure related to the drug, and two years later, the company said that there were no drug-related deaths at a urology conference.
- Price Action: SESN shares are down 13.6% at $1.30 during the market session on the last check Wednesday.
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