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壽康集團(00575.HK)產品「Fortacin」於美國研究取得十分優秀成果
阿思達克 07-15 18:07
壽康集團(00575.HK)公布,旗下用於治療早洩的產品「Fortacin」,於美國第二期患者報告結果驗證研究取得十分優秀成果,安全性及效能獲確認,新數據將用於完善早已編製的最終第三期隨機化臨床試驗工作方案,以篩選合適的臨床地點以作可行適宜及良好臨床實踐。

集團預期,將於8月中旬之前向美國食品及藥品監督管理局提交研究結果,假設研究足以說服美國食品及藥品監督管理局,早洩困擾評估問卷可作為支持標籤或處方信息聲明的適當措施,關鍵的第三期隨機化臨床試驗工作研究可於下半年開始,可望於明年底提交新藥申請,而處方藥使用者費用法日期預期將為2023年底。

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