BRIEF-Veru Receives FDA Agreement To Advance Veru-111 Into Phase 3 Study In Hospitalized Covid-19 Patients At High Risk For Acu

Brief-VERU獲得美國食品和藥物管理局的協議，將VERU-111推進到住院的新冠肺炎急性冠脈綜合徵高危患者的3期研究

路透社 · 2021/03/01 22:57

March 1 (Reuters) - Veru Inc :
   * VERU RECEIVES FDA AGREEMENT TO ADVANCE VERU-111 INTO PHASE 3 STUDY IN HOSPITALIZED COVID-19 PATIENTS AT HIGH RISK FOR ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
   * VERU INC - VERU COMPLETES EXPEDITED END OF PHASE 2 TRIAL MEETING WITH FDA
   * VERU INC - PHASE 3 CLINICAL STUDY EXPECTED TO BEGIN IN APRIL 2021 WITH CLINICAL RESULTS EXPECTED IN CALENDAR Q4 2021
   * VERU INC - FDA AGREES TO ADVANCE VERU-111 INTO PHASE 3 CLINICAL STUDY IN HOSPITALIZED HIGH RISK COVID-19 PATIENTS TO CONFIRM POTENTIAL BENEFIT & RISK
   * VERU -FDA AGREES CLINICAL FINDINGS SUGGEST CLINICALLY MEANINGFUL BENEFIT FOR USE OF VERU-111 IN HOSPITALIZED COVID-19 PATIENTS AT HIGH RISK FOR ARDS

Source text for Eikon: Further company coverage:

((Reuters.Briefs@thomsonreuters.com;)

路透3月1日電-Veru Inc：*VERU獲得食品和藥物管理局的同意，將VERU-111推進到住院的新冠肺炎急性呼吸窘迫綜合徵高危患者的3期研究*Veru Inc-Veru完成與FDA的第二階段試驗會議的加速結束*Veru Inc-3期臨牀研究預計將於2021年4月開始，臨牀結果預計將於2021年第四季度公佈*VERU INC-FDA同意將VERU-111推進到住院的高危新冠肺炎患者的3期臨牀研究，以確認潛在的益處和風險*VERU-FDA同意臨牀研究結果表明，在住院的新冠肺炎患者中使用VERU-111對急性呼吸窘迫綜合徵的高危患者有臨牀意義的益處Eikon的源文本：進一步的公司報道：(Reurs.Briefs@thomsonreurs.com；)

譯文內容由第三人軟體翻譯。

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BRIEF-Veru Receives FDA Agreement To Advance Veru-111 Into Phase 3 Study In Hospitalized Covid-19 Patients At High Risk For Acu

BRIEF-Veru Receives FDA Agreement To Advance Veru-111 Into Phase 3 Study In Hospitalized Covid-19 Patients At High Risk For Acu

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