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Meridian Bioscience Pulls Out Revogene COVID-19 Test EUA Application

Meridian Bioscience Pulls Out Revogene COVID-19 Test EUA Application

子午线生物科学推出REVERGENE新冠肺炎测试EUA应用
Benzinga Real-time News ·  2021/02/23 22:33
  • After submitting a written response to the FDA's request for additional information on Meridian Bioscience Inc's (NASDAQ: VIVO) Revogene SARS-CoV-2 test on February 16 and further discussions with the FDA, the company decided to withdraw its Emergency Use Authorization (EUA) application.
  • The company plans to conduct a new clinical validation study and a Limit-of-Detection bridging study, with potential re-submission of a EUA application during Q3 of 2021.
  • Price Action: VIVO is down 3.39% at $22.23 on the last check Tuesday.
  • 在提交了对FDA要求提供更多信息的书面答复后子午线生物科学公司(纳斯达克:活体)2月16日进行Revogene SARS-CoV-2测试,并与FDA、该公司决定退出其紧急使用授权(EUA)应用程序。
  • 该公司计划进行一项新的临床验证研究和检测极限桥接研究,并有可能在2021年第三季度重新提交EUA申请。
  • 价格行动:Vivo周二尾盘跌3.39%,报22.23美元。

译文内容由第三方软件翻译。


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