60 Degrees Pharmaceuticals Announces Communication From The FDA Of Intention To Respond To Tafenoquine-Babesiosis Trial Protocol Submission In April, 2024
60 Degrees Pharmaceuticals Announces Communication From The FDA Of Intention To Respond To Tafenoquine-Babesiosis Trial Protocol Submission In April, 2024
60 Degrees Pharmaceuticals, Inc., (NASDAQ:SXTP, SXTPW))))) ("60 Degrees Pharmaceuticals" or the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company's babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company's existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame.
專注於開發傳染病新藥的製藥公司60 Degrees Pharmicals, Inc.（納斯達克股票代碼：SXTP，SXTPW）））（“60 Degrees Pharmicals” 或 “公司”）今天宣佈，美國食品藥品監督管理局（FDA）已表示打算在2024年4月而不是預期的2024年3月就該公司的巴貝斯蟲病試驗發表任何評論公司。從技術上講，FDA指示的協議提交機制，即在公司現有（而不是新的）研究性新藥申請下，不需要FDA在規定的時間範圍內做出回應。
The Company is continuing preparations for a June 1, 2024 start date as previously communicated.
如先前所述，公司正在繼續爲2024年6月1日的開始日期做準備。
譯文內容由第三人軟體翻譯。