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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

Fisco Japan ·  Oct 3 08:15

Massive backlash. The conditions for acute respiratory distress syndrome (ARDS) treatment drugs and the decision to implement a time-limited approval application in Japan were announced. In addition to the good results of the phase 2 test completed in Japan and the phase 2 test conducted in the US and the UK, it was decided to apply for domestic conditions and time-limited approval on the assumption that the REVIVE-ARDS test will be carried out as a verification test. As a result, phase 3 trials within Japan, where clinical trial planning notifications have been submitted, are also no longer necessary, so they are scheduled to be canceled, and it is said that details will be announced as soon as they are decided along with preparations for the start of global phase 3 trials in the United States.

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