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Zivo Bioscience Said USDA Letter Affirmed Agency Has Claimed Jurisdiction for Reviewing the Company's Novel Immune-Modulating Biologic for Treating Coccidiosis in Broiler Chickens
Zivo Bioscience Said USDA Letter Affirmed Agency Has Claimed Jurisdiction for Reviewing the Company's Novel Immune-Modulating Biologic for Treating Coccidiosis in Broiler Chickens
In August 2022, Zivo Bioscience, Inc. (the "Company") announced receipt of a letter from the U.S. Department of Agriculture's (USDA) Center for Veterinary Biologics (CVB) affirming that the agency has claimed jurisdiction for reviewing the Company's novel immune-modulating biologic for treating coccidiosis in broiler chickens. Following a comprehensive review of data from several of ZIVO's efficacy studies, MOA studies and manufacturing processes, the CVB verified ZIVO's product is of biological origin and functions through an immune-modulating MOA that has no direct antimicrobial activity, and therefore is subject to their regulatory review. While other products for the control of coccidiosis delivered in feed are regulated by the U.S. FDA's Center for Veterinary Medicine, CVB's jurisdictional announcement removes regulatory ambiguity while providing a path forward for a comprehensive review. Commercialization Strategy The Company continues to actively pursue opportunities to license its product candidates. The Company is currently continuing its ongoing discussions with a major animal health company to potentially license its product candidate. New Study in Poultry Gut Health One of the Company's potential strategic partners intends to begin a new 42-day in vivo study of the Company's novel product candidate for the treatment of coccidiosis in chickens, to validate the efficacy of the active material. The Company anticipates this study will begin in September 2022, with final analysis and results expected in the first quarter of 2023.
In August 2022, Zivo Bioscience, Inc. (the "Company") announced receipt of a letter from the U.S. Department of Agriculture's (USDA) Center for Veterinary Biologics (CVB) affirming that the agency has claimed jurisdiction for reviewing the Company's novel immune-modulating biologic for treating coccidiosis in broiler chickens. Following a comprehensive review of data from several of ZIVO's efficacy studies, MOA studies and manufacturing processes, the CVB verified ZIVO's product is of biological origin and functions through an immune-modulating MOA that has no direct antimicrobial activity, and therefore is subject to their regulatory review. While other products for the control of coccidiosis delivered in feed are regulated by the U.S. FDA's Center for Veterinary Medicine, CVB's jurisdictional announcement removes regulatory ambiguity while providing a path forward for a comprehensive review. Commercialization Strategy The Company continues to actively pursue opportunities to license its product candidates. The Company is currently continuing its ongoing discussions with a major animal health company to potentially license its product candidate. New Study in Poultry Gut Health One of the Company's potential strategic partners intends to begin a new 42-day in vivo study of the Company's novel product candidate for the treatment of coccidiosis in chickens, to validate the efficacy of the active material. The Company anticipates this study will begin in September 2022, with final analysis and results expected in the first quarter of 2023.
2022年8月,Zivo Bioscience,Inc.(“该公司”)宣布收到美国农业部(USDA)兽医生物制品中心(CVB)的一封信,确认该机构已声称有权审查该公司治疗肉鸡球虫病的新型免疫调节生物制剂。在对Zivo的几项疗效研究、MOA研究和制造工艺的数据进行全面审查后,CVB通过一种没有直接抗菌活性的免疫调节MOA验证了Zivo的产品具有生物来源和功能,因此受到他们的监管审查。虽然其他用于控制饲料中球虫病的产品受到美国FDA兽医中心的监管,但CVB的管辖公告消除了监管的含糊不清之处,同时为全面审查提供了前进道路。商业化战略该公司继续积极寻求机会,以获得其候选产品的许可。该公司目前正在继续与一家大型动物保健公司进行谈判,以可能获得其候选产品的许可。家禽肠道健康的新研究该公司的潜在战略合作伙伴之一打算开始一项为期42天的新的体内研究,对该公司治疗鸡球虫病的新产品候选进行研究,以验证活性材料的疗效。该公司预计这项研究将于2022年9月开始,最终分析和结果预计将在2023年第一季度开始。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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