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Thursday, January 19, 2017 12:13:54 PM
The IRB protocol was first approved by the hospital which will perform the safety study and after obtaining its approval the IRB protocol is being submitted for approval to the national IRB committee. The national IRB committee is scheduled to ensemble at the beginning of December 2016.
Upon the expected approval of the safety protocol by the national committee, the company will immediately engage with the study which will last approximately 12 weeks.
Results are expected by the end of March 2016 and upon reaching satisfactory results the company intends to start production, marketing and sales in the US and EU in parallel to local IL efforts.
The Safety study is designed to test multiple escalating doses to determine the safety and tolerability of the medical grade cannabis cream on healthy volunteers. The psoriasis topical crème infused with active cannabinoids is a unique delivery-system product of OWC designed to be used for skin diseases, where the first application will be tested for safety and efficacy for Psoriasis. The efficacy studies have already been started and results are expected by the end of Jan 2017.
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