Highly Specialized International FDA Regulatory Compliance Firm Signs With Cannabis Science to Prepare for Company's First Pre-Investigative New Drug (IND) Submission Package for Veterans PTSD Project
COLORADO SPRINGS, Colo., -- Cannabis Science, Inc. (OTCBB:CBIS), a pioneering pharmaceutical cannabis company, is pleased to announce that it has formalized its agreement with a privately owned, highly specialized international FDA regulatory compliance firm. The compliance firm will review and prepare technical data for Cannabis Science's FDA Pre-Investigative New Drug (IND) submission package for its Veterans PTSD Project. The compliance firm will also participate in the Pre-IND meetings for regulatory guidance and interactions with the FDA throughout the approval process. In addition, the compliance firm will provide high-level expertise in the steps following the IND approvals, including technical and regulatory writing of validation protocols for a comprehensive drug development program.
Dr. Robert Melamede, PhD., Cannabis Science President and CEO, explained, "This contract is a concrete demonstration of our progress in moving our first new drug product through the FDA process. Our FDA specialists will also provide Cannabis Science with high-level expertise in the steps following the IND approvals, such as providing process validation for biological product design and analytical development for clinical trials. The compliance firm will conduct the oversight for implementing cGMP (current good manufacturing procedures) regulations, technical writing for the manufacturing processes and required compliance audits of quality systems integration of the biopharmaceutical drug development. We believe that there is an urgent need for cannabis based medicines, and our strategy of minimizing corporate bureaucracy is the fastest and most economical way to our goals."
Richard Cowan, Cannabis Science CFO, added, "Signing this contract with a company that provides expert guidance to members of the biotechnology and pharmaceutical industries worldwide gives us the support of a large staff of professionals, many with advanced degrees in the relevant fields that would be difficult and expensive to duplicate in-house. Dr. Melamede has again demonstrated that his standing in the scientific community is such that the very best people want to help our company develop its products."
About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. In sum, we are dedicated to the creation of cannabis-based medicines, both with and without psychoactive properties, to treat disease and the symptoms of disease, as well as for general health maintenance.
Forward Looking Statements
This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing words such as "anticipate," "seek," intend," "believe," "plan," "estimate," "expect," "project," "plan," or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations regarding the use and development of cannabis-based drugs. Cannabis Science, Inc. does not undertake any duty nor does it intend to update the results of these forward-looking statements.