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Alterity Therapeutics 的 ATH434 第三期臨床試驗計畫獲得美國 FDA 支持

-- Alterity Therapeutics(ASX:ATH)週一向澳洲證券交易所提交的文件顯示,該公司在與美國食品藥品監督管理局(FDA)舉行的第二次C類會議上獲得了積極的反饋,該會議旨在討論其用於治療多系統萎縮症(MSA)的候選藥物ATH434的三期臨床試驗計劃。 MSA是一種進行性神經退化性疾病,會影響自主神經和運動功能,目前尚無核准的疾病修飾療法。 該文件還補充道,美國FDA就該計畫的化學、生產和控制方面提供了支持性的書面回饋,補充了先前在另一次C類會議上就臨床藥理學和非臨床開發方面提供的指導意見。

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