From the most recent 8k: So this was read by
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Posted On: 03/10/2017 1:12:23 PM
From the most recent 8k:
So this was read by many as IRB safety approval, whereas, it is approval to conduct safety efficacy trials on human skin tissue, correct? At least I thought that folks thought it was IRB safety approval...seems like safety testing is ongoing
Seems like the efficacy results have been known for a good while already......
- Quote from Dr. Baruch:
the results of our efficacy studies were so encouraging that management decided to extend the size and scope of the study to verify the biological markers that had been generated to date, among other things.
Item 8.01. Other Events.
The Registrant, in its press release attached hereto as Exhibit 99.1 to this 8-K, announced it has received Institutional Review Board (IRB) approval to conduct safety testing on its proprietary topical creme compound for the treatment of psoriasis and related skin conditions. Psoriasis is an autoimmune disease that causes red, scaly patches to appear on the skin, and can be associated with other serious health conditions, including diabetes, heart disease and depression. According to the National Psoriasis Foundation, psoriasis affects 7.5 million people in the United States.
The IRB approval follows the Company's February 1, 2017 8-K filing announcing an extension to the size and scope of its efficacy study on the same compound, which began in November 2106. The IRB-approved study encompasses the cream itself, as a delivery mechanism, as well as the proprietary psoriasis formulation, and is the first to formally make such claims with the NIH Registry. The double-blind study, which will be conducted on healthy volunteers at one of Israel's leading academic hospitals, is designed to demonstrate the safety of the formulation in treating psoriasis on human skin tissue.
Dr. Yehuda Baruch, the Company's Director of Research and Regulatory Affairs, stated "This approval is a significant milestone for OWC, where our mission is to bring the same rigorous approach common to traditional pharmaceutical development to the medical cannabis field. As we reported earlier, the results of our efficacy studies were so encouraging that management decided to extend the size and scope of the study to verify the biological markers that had been generated to date, among other things. "
Ziv Turner, the Company's Vice President of Business Development and Managing Director of One World Cannabis, Ltd., the Company's wholly-owned subsidiary, added, "immediately following announcement of the Company's psoriasis treatment formulation, we began receiving requests for our topical psoriasis cream product from patients suffering from the condition. After several years of extensive commitment to R&D, we now expect that the Company should be in position to bring our psoriasis cream product to the market during the second quarter of 2017 or soon thereafter."
Reference is made to the full text of the press release filed as Exhibit 99.1 herewith.
So this was read by many as IRB safety approval, whereas, it is approval to conduct safety efficacy trials on human skin tissue, correct? At least I thought that folks thought it was IRB safety approval...seems like safety testing is ongoing
Seems like the efficacy results have been known for a good while already......
- Quote from Dr. Baruch:
the results of our efficacy studies were so encouraging that management decided to extend the size and scope of the study to verify the biological markers that had been generated to date, among other things.
Item 8.01. Other Events.
The Registrant, in its press release attached hereto as Exhibit 99.1 to this 8-K, announced it has received Institutional Review Board (IRB) approval to conduct safety testing on its proprietary topical creme compound for the treatment of psoriasis and related skin conditions. Psoriasis is an autoimmune disease that causes red, scaly patches to appear on the skin, and can be associated with other serious health conditions, including diabetes, heart disease and depression. According to the National Psoriasis Foundation, psoriasis affects 7.5 million people in the United States.
The IRB approval follows the Company's February 1, 2017 8-K filing announcing an extension to the size and scope of its efficacy study on the same compound, which began in November 2106. The IRB-approved study encompasses the cream itself, as a delivery mechanism, as well as the proprietary psoriasis formulation, and is the first to formally make such claims with the NIH Registry. The double-blind study, which will be conducted on healthy volunteers at one of Israel's leading academic hospitals, is designed to demonstrate the safety of the formulation in treating psoriasis on human skin tissue.
Dr. Yehuda Baruch, the Company's Director of Research and Regulatory Affairs, stated "This approval is a significant milestone for OWC, where our mission is to bring the same rigorous approach common to traditional pharmaceutical development to the medical cannabis field. As we reported earlier, the results of our efficacy studies were so encouraging that management decided to extend the size and scope of the study to verify the biological markers that had been generated to date, among other things. "
Ziv Turner, the Company's Vice President of Business Development and Managing Director of One World Cannabis, Ltd., the Company's wholly-owned subsidiary, added, "immediately following announcement of the Company's psoriasis treatment formulation, we began receiving requests for our topical psoriasis cream product from patients suffering from the condition. After several years of extensive commitment to R&D, we now expect that the Company should be in position to bring our psoriasis cream product to the market during the second quarter of 2017 or soon thereafter."
Reference is made to the full text of the press release filed as Exhibit 99.1 herewith.
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