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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.(“該公司”)宣佈收到美國農業部(USDA)獸醫生物製品中心(CVB)的一封信,確認該機構已聲稱有權審查該公司治療肉雞球蟲病的新型免疫調節生物製劑。在對Zivo的幾項療效研究、MOA研究和製造工藝的數據進行全面審查後,CVB通過一種沒有直接抗菌活性的免疫調節MOA驗證了Zivo的產品具有生物來源和功能,因此受到他們的監管審查。雖然其他用於控制飼料中球蟲病的產品受到美國FDA獸醫中心的監管,但CVB的管轄公告消除了監管的含糊不清之處,同時為全面審查提供了前進道路。商業化戰略該公司繼續積極尋求機會,以獲得其候選產品的許可。該公司目前正在繼續與一家大型動物保健公司進行談判,以可能獲得其候選產品的許可。家禽腸道健康的新研究該公司的潛在戰略合作伙伴之一打算開始一項為期42天的新的體內研究,對該公司治療雞球蟲病的新產品候選進行研究,以驗證活性材料的療效。該公司預計這項研究將於2022年9月開始,最終分析和結果預計將在2023年第一季度開始。
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
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., 是關聯公司。
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