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
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