Post by icemandios on Aug 18, 2021 17:29:14 GMT
Sesen Bio trial marred by misconduct — report
Kyle Blankenship
Managing Editor
Max Gelman
Editor
Josh Sullivan
Associate Editor
Sesen Bio said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum. But the rejected filing included thousands of violations and investigator misconduct, STAT News reported Wednesday.
The 130-patient study had more than 2,000 violations, 215 of which were classified as major, STAT said. 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.
The company saw its stock crash, as it entered a halt at $6 per share last Friday and emerged battered with a $0.86 price.
In June CEO Thomas Cannell said that the drug was on its way to generating between $1 billion and $3 billion. Then Monday, he blamed “toxic” and critical media coverage of the FDA’s approval of Biogen’s Alzheimer’s treatment Aduhelm for the CRL. — Josh Sullivan
Kyle Blankenship
Managing Editor
Max Gelman
Editor
Josh Sullivan
Associate Editor
Sesen Bio said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum. But the rejected filing included thousands of violations and investigator misconduct, STAT News reported Wednesday.
The 130-patient study had more than 2,000 violations, 215 of which were classified as major, STAT said. 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.
The company saw its stock crash, as it entered a halt at $6 per share last Friday and emerged battered with a $0.86 price.
In June CEO Thomas Cannell said that the drug was on its way to generating between $1 billion and $3 billion. Then Monday, he blamed “toxic” and critical media coverage of the FDA’s approval of Biogen’s Alzheimer’s treatment Aduhelm for the CRL. — Josh Sullivan