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BRIEF-Tenax meets with FDA to discuss positive mortality data and potential levosimendan NDA submission
2017年5月16日 / 晚上9点19分 / 2 个月内

BRIEF-Tenax meets with FDA to discuss positive mortality data and potential levosimendan NDA submission

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May 16 (Reuters) - Tenax Therapeutics Inc

* Tenax meets with FDA to discuss positive mortality data and potential levosimendan NDA submission

* Tenax Therapeutics - Analysis of pre-specified LEVO-CTS subgroup of isolated CABG surgery patients indicates a 73% reduction in 90-day all-cause mortality

* Tenax Therapeutics - Mortality reduction in LEVO-CTS isolated CABG patients is consistent with study hypothesis and data from previously published trials

* Tenax Therapeutics Inc - FDA requested submission of additional information from published cross study analyses that were presented during meeting

* Tenax - Met with FDA on May 10 to review additional data analyses from phase 3 LEVO-CTS clinical study of levosimendan in cardiac surgery patients at LCOS risk Source text for Eikon: Further company coverage:

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