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On February 16, 2024, Incannex Healthcare Inc., a biotechnology company specializing in cannabinoid and psychedelic medicine, announced the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for their product CannQuit-N, a novel tobacco smoking cessation solution. The meeting involved discussions on the regulatory aspects of CannQuit-N's development program, with the FDA providing recommendations on clinical trial design, including efficacy and safety endpoints, and confirming the appropriateness of manufacturing and quality control strategies. CannQuit-N is a medicated chewing gum that combines cannabidiol (CBD) with nicotine, aiming to assist smokers in quitting more effectively than traditional nicotine replacement therapies. Incannex holds patents for this combination and anticipates growth in the nicotine replacement therapy market. The company is also developing treatments for various conditions, including obstructive sleep apnoea and traumatic brain injury, with a strong patent strategy and 19 granted patents. This announcement was approved by Incannex's Board of Directors for release to NASDAQ.
On February 16, 2024, Incannex Healthcare Inc., a biotechnology company specializing in cannabinoid and psychedelic medicine, announced the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for their product CannQuit-N, a novel tobacco smoking cessation solution. The meeting involved discussions on the regulatory aspects of CannQuit-N's development program, with the FDA providing recommendations on clinical trial design, including efficacy and safety endpoints, and confirming the appropriateness of manufacturing and quality control strategies. CannQuit-N is a medicated chewing gum that combines cannabidiol (CBD) with nicotine, aiming to assist smokers in quitting more effectively than traditional nicotine replacement therapies. Incannex holds patents for this combination and anticipates growth in the nicotine replacement therapy market. The company is also developing treatments for various conditions, including obstructive sleep apnoea and traumatic brain injury, with a strong patent strategy and 19 granted patents. This announcement was approved by Incannex's Board of Directors for release to NASDAQ.
2024年2月16日，专门从事大麻素和迷幻药物的生物技术公司Incannex Healthcare Inc. 宣布成功完成了与美国食品药品监督管理局（FDA）就其产品Cannquit-N（一种新型烟草戒烟解决方案）举行的IND前会议。会议讨论了Cannquit-N开发计划的监管方面，美国食品药品管理局就临床试验设计提供了建议，包括疗效和安全终点，并确认了制造和质量控制策略的适当性。Cannquit-n是一种药用口香糖，它结合了大麻二酚（CBD）和尼古丁，旨在比传统的尼古丁替代疗法更有效地帮助吸烟者戒烟。Incannex拥有这种组合的专利，并预计尼古丁替代疗法市场的增长。该公司还在开发各种疾病的治疗方法，包括阻塞性睡眠呼吸暂停和创伤性脑损伤，拥有强大的专利战略和19项已获授权的专利。该公告已获得Incannex董事会的批准，将在纳斯达克发布。
2024年2月16日，专门从事大麻素和迷幻药物的生物技术公司Incannex Healthcare Inc. 宣布成功完成了与美国食品药品监督管理局（FDA）就其产品Cannquit-N（一种新型烟草戒烟解决方案）举行的IND前会议。会议讨论了Cannquit-N开发计划的监管方面，美国食品药品管理局就临床试验设计提供了建议，包括疗效和安全终点，并确认了制造和质量控制策略的适当性。Cannquit-n是一种药用口香糖，它结合了大麻二酚（CBD）和尼古丁，旨在比传统的尼古丁替代疗法更有效地帮助吸烟者戒烟。Incannex拥有这种组合的专利，并预计尼古丁替代疗法市场的增长。该公司还在开发各种疾病的治疗方法，包括阻塞性睡眠呼吸暂停和创伤性脑损伤，拥有强大的专利战略和19项已获授权的专利。该公告已获得Incannex董事会的批准，将在纳斯达克发布。
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