The Company has received from our consultants its initial review for Pre-IND preparation work and for the submitting Pre-IND request letter. With several questions answered and confirmed for the Company, the Company will sign off and its’ consultants will prepare the Pre-IND meeting submission package.
The Company and its FDA specialists understand the regulatory strategy and guidance, the timelines for preparation, and the conduct required at the FDA pre-IND meeting. These timelines are determined by FDA policy with the aim of facilitating the application process. The budget review was positive and realistic consisting of estimates of consultant hours, costs, activities, recurring activities, travel and other direct expenses.
Federal law requires that a marketing application for a new drug be approved before the drug can be transported or distributed over state lines. A sponsor will want to ship the investigational drug to clinical investigators, and therefore must seek an exemption from any existing legal restrictions. When a drug is in preclinical development, the sponsor’s primary goal is to make sure the product is safe for initial testing on humans and that the pharmacological activity justifies commercial development. When a product is determined to be a viable candidate for further development, the sponsor collects data and information necessary to establish that the product will not harm humans or exposes them to unreasonable risks when used in limited clinical studies.
Cannabis Science and cancer patients look forward to benefiting from the company’s formulations when they become available on the mainstream market. Cannabis Science is confident as to the efficacy of its products since they are currently used by patients on a limited intra-state basis.
About Cannabis Science, Inc. Cannabis Science, Inc. is at the forefront of pharmaceutical grade medical marijuana research and development. The second formulations will address the needs of patients choosing to use concentrated cannabis extracts to treat their ailments. Eventually, all Americans will have access to a safe and effective FDA approved medicine regardless of which state they live in. To maintain that marijuana is a dangerous, addictive drug with no medical value is scientifically absurd. Cannabis medicines, with no effective lethal dose, are far safer than aspirin, acetaminophen, and most other OTC drugs that kill thousands of Americans every year.
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 works 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.
