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Psycheceutical Bioscience, Inc. (OTCPK: BWVI) has entered into an exclusive agreement with iNGENū Pty Ltd to conduct human clinical trials for its NeuroDirect™ ketamine topical delivery system in Australia. The Phase I trial will evaluate safety and pharmacokinetics in 20 healthy volunteers, while the Phase II trial aims to assess effectiveness in 115 PTSD patients. The company anticipates potential FDA recognition for a pivotal clinical trial, allowing a direct transition to Phase III, which could save significant time and costs. Additionally, conducting trials in Australia allows Psycheceutical to benefit from a 43.5% R&D tax rebate, reducing capital expenditure.
Psycheceutical Bioscience, Inc. (OTCPK: BWVI) announced its intention to pursue the 505(b)(2) regulatory pathway for a novel topical formulation of ketamine aimed at treating PTSD. After a pre-Investigational New Drug (IND) meeting with the FDA, positive guidance was received for IND-enabling studies and clinical trial designs. The company plans to file an IND by the end of 2023, seeking potential accelerated approval via FDA expedited programs. The NeuroDirect™ technology aims for non-systemic delivery directly to nerve tissue, avoiding typical systemic side effects, and facilitating patient care at home, ultimately making treatments more accessible.
Psycheceutical Bioscience, Inc. (OTC: BWVI) has filed a provisional patent application for the first topical ketamine formulation aimed at treating post-traumatic stress disorder (PTSD). This innovative product utilizes NeuroDirect™, a non-systemic delivery technology designed to distribute neuro-active compounds effectively to the back of the neck, reducing common side effects like hallucinations and nausea. The company aims to provide affordable, life-saving treatments for mental health disorders, leveraging telehealth options for easier access. With PTSD affecting millions, this development represents a significant step towards improving treatment methodologies for those in need.
Psycheceutical Bioscience, Inc. (OTCPK: BWVI) has appointed Dr. Julian Bailes as Chief Medical Officer and a Board member. He will spearhead the company's clinical and technological development as they prepare for clinical trials of their psychedelic drug delivery systems later this year. Dr. Bailes, known for his expertise in neurosurgery and brain injury, aims to enhance mental health treatments. His leadership is expected to bolster the company's strategy in adhering to regulatory compliance and cultivating partnerships for innovative drug delivery solutions.
Psycheceutical Bioscience, Inc. (OTC: BWVI) announced the appointment of Dr. Aric Logsdon as its Scientific Director on November 29, 2022. Dr. Logsdon, an expert in neuroscience, will lead the company’s drug development initiatives and clinical trial pipeline focusing on psychedelic treatments for mental health issues. With over 50 peer-reviewed publications and experience at the U.S. Department of Veterans Affairs, Dr. Logsdon aims to enhance the company’s patented drug-delivery technology. Psycheceutical is committed to advancing safe and effective psychedelic therapies.
Psycheceutical Bioscience (OTC: BWVI) has announced the formation of a Medical Advisory Board led by renowned neurosurgeon Dr. Julian Bailes. The Board will guide the company in developing innovative psychedelic medicine technologies aimed at improving mental health treatments. Key members include Dr. Thomas Cabell, a cardiologist, and Dr. Tony Strickland, a neuropsychologist. This strategic move is expected to enhance Psycheceutical's research and drug delivery capabilities, bringing their advanced therapies closer to market.
Psycheceutical Bioscience (OTC: BWVI) announced the appointment of its Chief Visionary Officer, Zappy Zapolin, to Benzinga’s Psychedelics Advisory Council. This council, created in March 2022, comprises influential figures in psychedelic medicine. Zapolin's expertise aims to enhance awareness of emerging psychedelic therapies, particularly in addiction and mental health treatments. His involvement is expected to provide strategic insights through various media formats. The company focuses on developing innovative delivery technologies for psychedelic pharmaceuticals, supported by a seasoned management team.
Psycheceutical Bioscience (OTC: BWVI) announced that CEO Chad Harman will present an overview of the company at the Life Sciences Investor Forum on September 15, 2022. Harman will discuss Psycheceutical's mission to develop innovative technologies for psychedelic pharmaceuticals and their applications in mental health treatment. The event will be held online, providing access to a wide range of investors. Psycheceutical aims to improve the safe delivery of psychedelics through their patented technologies, addressing side effects associated with traditional methods.
Psycheceutical Bioscience, Inc. (OTC: BWVI) has announced an exclusive option to acquire a majority equity stake in Vici Health Sciences for approximately $10.5 million, payable in cash and equity. This option must be exercised by April 2023. The acquisition aims to enhance Psycheceutical’s development pipeline for mental health treatments using psychedelic compounds, leveraging Vici’s pharmaceutical R&D capabilities. Anish Dhanarajan, CEO of Vici, will also serve as a Research and Development Advisor at Psycheceutical.
Psycheceutical, Inc. (OTC: BWVI) has welcomed entrepreneur Kevin Harrington as an investor and strategic advisor. Harrington aims to leverage his expertise to enhance the company's mission of developing psychedelic pharmaceuticals to combat mental health issues. He emphasizes the need for innovative treatment options and is particularly interested in Psycheceutical's patented delivery technologies that enhance safety and efficacy without hallucinogenic effects. The company, backed by a seasoned team, is focused on advancing research and the commercialization of psychedelic medicines for mental health treatment.
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