share_log

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

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

Brief-sesen Bio表示，FDA在Vicineum的3期試驗中向前研究調查員發出警告信
reuters ·  2021/10/27 17:06

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

路透10月27日電-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-10月27日，FDA發佈了一封警告信，發給CO的Vista第三階段試驗中的一名前研究調查員，要求提交VICINEUM-SEC文件

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

*SESEN BIONIC-4年多前當CO得知與Vista試驗無關的調查員的專業不當行為時，停止使用研究調查員

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

*SESEN BIO-FDA警告信表明研究調查員沒有遵守進行臨牀調查的法定要求

* 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生物研究調查員運營着一個臨牀網站，該網站之前是Vista試驗的一部分，該試驗於2017年5月26日被CO關閉

* 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生物研究調查員的行醫執照於2017年5月29日暫時吊銷，原因是記錄不準確，與CO無關，患者在Vista試驗中

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

*SESEN BIO Inc.-在提交給FDA的BLA中包括臨牀現場的相應患者數據

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

*SESEN生物公司在FDA審查VICINEUM的BLA期間沒有收到任何警告信或紀律審查信

Source text: [ Further company coverage: SESN.O

源文本：[進一步的公司報道：SESN.O

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

(Reurs.Briefs@thomsonreurs.com；)

声明：本內容僅用作提供資訊及教育之目的，不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論