壽康集團(00575.HK):FortacinTM美國第二期患者報吿結果驗證研究取得十分優秀成果
格隆匯7月15日丨壽康集團(00575.HK)發佈公吿,來自美國16號中心對驗證美國食品及藥品監督管理局有關早泄的強制性患者報吿結果所進行研究的事前數據分析已順利完成。患者報吿結果、早泄困擾評估問卷已按符合美國食品及藥品監督管理局指引制訂,作為評估早已在美國規劃的第三期隨機化臨牀試驗工作效能的最終關鍵步驟。
集團預期將於2021年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。假設研究足以説服美國食品及藥品監督管理局,早泄困擾評估問卷TM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牀試驗工作研究可於2021年下半年開始,新藥申請可望於2022年底提交,而處方藥使用者費用法的日期因此將為2022年底。
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