Cannabis Science Continues Forward with FDA IND Process as Patients Report Successful Cancer Treatments
DENVER, Apr 02, 2012 (BUSINESS WIRE) -- Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech company developing cannabis pharmaceutical and over the counter nutraceutical products, is pleased to report it is moving forward with its FDA IND process. We have kept the public up to date with self-medicated skin cancer patients who are benefiting from topical cannabis-based extracts. These patients have experienced dramatic reduction in tumor burden and for some apparent eradication of their skin cancers.
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(EQNX::rightsinglequotation) 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(EQNX::rightsinglequotation)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(EQNX::rightsinglequotation)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. |
