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BRIEF-Sesen Bio Says FDA Issued Warning Letter To Former Study Investigator In Phase 3 Trial For Vicineum

reuters ·  Oct 27, 2021 17:06

Oct 27 (Reuters) - Sesen Bio Inc SESN.O :

* SESEN BIO - ON OCT 27, FDA PUBLISHED A WARNING LETTER ISSUED TO A FORMER STUDY INVESTIGATOR IN CO'S PHASE 3 VISTA TRIAL FOR VICINEUM - SEC FILING

* SESEN BIO - DISCONTINUED USE OF STUDY INVESTIGATOR OVER 4 YRS AGO WHEN CO LEARNED OF PROFESSIONAL MISCONDUCT BY INVESTIGATOR UNRELATED TO VISTA TRIAL

* SESEN BIO - FDA WARNING LETTER INDICATES STUDY INVESTIGATOR DID NOT COMPLY WITH STATUTORY REQUIREMENTS REGARDING CONDUCT OF CLINICAL INVESTIGATIONS

* SESEN BIO - STUDY INVESTIGATOR OPERATED A CLINICAL SITE THAT WAS PREVIOUSLY PART OF THE VISTA TRIAL, WHICH WAS CLOSED BY CO ON MAY 26, 2017

* SESEN BIO - STUDY INVESTIGATOR'S MEDICAL LICENSE TEMPORARILY SUSPENDED ON MAY 29, 2017 DUE TO INACCURATE RECORDKEEPING, UNASSOCIATED WITH CO, PATIENTS IN VISTA TRIAL

* SESEN BIO INC - INCLUDED CORRESPONDING PATIENT DATA FROM CLINICAL SITE IN ITS BLA SUBMISSION TO FDA

* SESEN BIO - COMPANY DID NOT RECEIVE ANY WARNING LETTERS OR DISCIPLINE REVIEW LETTERS DURING THE FDA’S REVIEW OF THE BLA FOR VICINEUM

Source text: [ Further company coverage: SESN.O

((Reuters.Briefs@thomsonreuters.com;))

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