This is a topical creme. Nothing is ingested, therefore the clinical trials are different from what you'd expect of a new, ingested medicine.
Also, this is cannabis based. Cannabis is not unsafe. IMHO the safety study is a mere formality.
Once the Sheba Hospital study drops, the creme will begin sales worldwide.
There are years of research for the psoriasis creme, as outlined in the 2017 letter to shareholders:
Our Cannabinoid-Based Cream for Psoriasis
In March, 2016 we reported the completion of the formulation of a topical compound designed to ensure the effective delivery and dosage of a proprietary cannabinoid-based topical cream for psoriasis. This formulation was developed through a strategic relationship with Israel-based Emilia Cosmetics Ltd., one of the country's largest cosmetic manufacturers.
Psoriasis is an autoimmune disease that results in red, scaly patches appearing on the skin. It can be associated with other medical conditions and disorders including diabetes, heart disease and depression, and often is very painful and uncomfortable. Skin cells in patients with psoriasis grow at an abnormally fast rate frequently causing a buildup of lesions that can burn and itch. An estimated 8.5 million individuals suffer from psoriasis in the United States and Canada, with an estimated 2.5% of the world's population suffering from the disease.
In March, we reported that OWCP had completed the Institutional Review Board ("IRB") protocol for a Phase I equivalent, double-blind, randomized and placebo-controlled study for our psoriasis cream. The initial study comprised multiple-increasing dosages to determine the safety, tolerability, and pharmacokinetic profile of the cream in healthy volunteers.
In September, OWCP announced that it had signed a funding and license agreement with U.S.-based Medmar LLC. As part of the agreement, Medmar provided US$300,000 in the form of a loan, repayable from royalties obtained from specific OWCP's licensed products in the U.S. The funds are being utilized to complete the development of OWCP's psoriasis cream. As part of the agreement, Medmar obtained certain rights to manufacture, produce, publicize, promote, and market OWC's products in the United States.
In October, OWCP announced that it had begun the final phase of efficacy testing for its psoriasis cream. The Company completed its challenge-testing, successfully demonstrated the product's robustness against microbiological contamination and stability, and provided a preliminary safety assessment. The Company also announced a parallel test to assess the efficacy of the formulation in treating psoriasis in human skin tissue.
In November, OWCP announced that it had entered into an agreement with Europe-based Michepro Holding Ltd. ("Michepro"). The agreement provided for both an investment by Michepro of US$300,000 in OWCP's common stock, and also the formation of a jointly-owned company, owned 75 percent by OWCP and 25 percent by Michepro to promote, sell, and market OWCP's products in Europe, starting with the Company's psoriasis cream.
In November, OWCP announced that it was submitting the safety protocol for our psoriasis cream to Israel's national Institutional Review Board. The study is currently underway and the results are expected by the end of March, 2017.
In late December, OWCP entered into a research agreement with a major Israel-based medical center for the performance of a Phase I, double-blind, randomized, placebo-controlled, maximal dose study to determine the safety and tolerability of the Company's psoriasis cream. This study is now underway.
OWCP is hopeful that the psoriasis cream will be launched in the U.S. and European markets and we anticipate market readiness and the start of marketing efforts during Q2 - 2017 on a state to state basis and subject to state regulations.
