Thursday, November 14, 2019 11:40:29 AM
“Our first patent-pending product candidate, CVSI-007, combines CBD and nicotine in treatment of smokeless tobacco use and addiction. There are currently no drugs approved by the U.S. Food & Drug Administration (“FDA”) for treatment of smokeless tobacco use and addiction. We believe this product candidate will provide treatment options for this significant unmet medical need. We are hopeful to be in a position to file an Investigational New Drug Application (“IND”) with the FDA in the next 12 months. We completed a pre-IND meeting with the FDA in June 2017 and obtained guidance on this development program. CVSI-007 is based on proprietary formulations, processes and technology that we believe are patent-protectable. In May 2016, we filed a patent application for these formulations and processes with the U.S. Patent and Trademark Office. We are awaiting notice of a hearing with the U.S. Patent and Trademark Office. We anticipate the hearing to take place during 2019.
Recent CVSI News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 01:10:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/12/2023 02:36:49 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2023 08:21:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2023 01:32:15 PM
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