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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期试验中向前研究调查员发出警告信
reuters ·  2021/10/27 17:06

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

路透10月27日电-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发布了一封警告信，发给CO的Vista第三阶段试验中的一名前研究调查员，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年多前当CO得知与Vista试验无关的调查员的专业不当行为时，停止使用研究调查员

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

*SESEN BIO-FDA警告信表明研究调查员没有遵守进行临床调查的法定要求

* 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生物研究调查员运营着一个临床网站，该网站之前是Vista试验的一部分，该试验于2017年5月26日被CO关闭

* 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生物研究调查员的行医执照于2017年5月29日暂时吊销，原因是记录不准确，与CO无关，患者在Vista试验中

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

*SESEN BIO Inc.-在提交给FDA的BLA中包括临床现场的相应患者数据

* 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审查VICINEUM的BLA期间没有收到任何警告信或纪律审查信

Source text: [ Further company coverage: SESN.O

源文本：[进一步的公司报道：SESN.O

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

(Reurs.Briefs@thomsonreurs.com；)

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