Biotechnology company Pasithea Therapeutics Corp. (KTTA) announced Wednesday receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding clinical development plan for PAS-004.The FDA's positive feedback and guidance include a recommendation to begin dosing in patients who will benefit from treatment rather than in healthy volunteers.

生物技术公司Pasithea Therapeutics Corp.（KTTA）宣布周三收到与美国食品和药物管理局（FDA）就PAS-004临床开发计划就第2类研究前新药申请（IND）会议提交的问题的书面回复。FDA的积极反馈和指导包括建议开始给药的患者受益于治疗而不是健康的志愿者。

PAS-004 was granted orphan drug designation for the treatment of NF1 in November 2020.The company said it will begin dosing as early as the first quarter of 2024 following acceptance of the IND by the FDA..

PAS-004于2020年11月被授予用于治疗NF1的孤儿药名称。该公司表示，在FDA接受IND后，它将于2024年第一季度开始给药。。

PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies to support an IND application with the FDA that it plans to submit in the fourth quarter of 2023. For comments and feedback contact: editorial@rttnews.comBusiness News.

PAS-004已经在各种疾病的小鼠模型中进行了测试，并完成了临床前测试和动物毒理学研究，以支持FDA计划在2023年第四季度提交的IND申请。有关意见和反馈，请联系：editorial@rttnews.combusiness新闻。

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