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Incannex Completes Successful Pre-IND Meeting with the FDA for CannQuit-N; a Novel Solution for Tobacco Smoking Cessation

Incannex Healthcare Inc. (IXHL) 
Company Research Source: GlobeNewswire
MELBOURNE, Australia and NEW YORK, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-N for tobacco smoking cessation and control of relapse. The pre-IND teleconference included representatives from various divisions of the FDA covering all regulatory aspects of the CannQuit-N development program. The Agency had reviewed the CannQuit-N meeting package and provided recommendations on key design aspects of the proposed clinical trials, including the timing of efficacy endpoints and specific details on safety endpoints. The FDA also confirmed proposed strategies for manufacturing and quality control are appropriate. The productive discussion with the FDA is an important milestone Show less Read more
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