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.
专注于开发传染病新药的制药公司60 Degrees Pharmicals, Inc.（纳斯达克股票代码：SXTP，SXTPW）））（“60 Degrees Pharmicals” 或 “公司”）今天宣布，美国食品药品监督管理局（FDA）已表示打算在2024年4月而不是预期的2024年3月就该公司的巴贝斯虫病试验发表任何评论公司。从技术上讲，FDA指示的协议提交机制，即在公司现有（而不是新的）研究性新药申请下，不需要FDA在规定的时间范围内做出回应。
The Company is continuing preparations for a June 1, 2024 start date as previously communicated.
如先前所述，公司正在继续为2024年6月1日的开始日期做准备。