Helios - significant rebound, decision to implement conditional and time-limited approval application for ARDS treatment drug in japan

Fisco Japan · Oct 2 20:15

Marked rebound. It was announced the decision to conduct conditional and time-limited approval applications for the treatment of acute respiratory distress syndrome (ARDS) in Japan. In addition to the favorable results of the Phase 2 trials completed in Japan and the United States and the United Kingdom, it was decided to submit a conditional and time-limited approval application in Japan, assuming the conduct of the REVIVE-ARDS trial as a verification trial. As a result, since the Phase 3 trial in Japan, for which a clinical trial plan notification had been submitted, is no longer necessary, it is planned to cancel it, and preparations will be made for the start of the global Phase 3 trial in the USA, with details to be announced as they are determined.

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ヘリオス---大幅反発、日本におけるARDS治療薬の条件及び期限付承認申請実施の決定

Helios - significant rebound, decision to implement conditional and time-limited approval application for ARDS treatment drug in japan

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