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Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) announces the completion of a pre-Investigational Device Exemption (pre-IDE) meeting with the U.S. Food and Drug Administration's (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health to discuss Stellar's proposed anti-KLH assay currently in development.
The outcome of this consultation with the FDA assisted Stellar to identify and define its strategy to complete the clinical development and regulatory pathway for the anti-KLH in vitro diagnostic device. The FDA encouraged Stellar to consider additional clinical investigation plans that may distinguish the clinical correlation of the assay results with measures of patient immune response.
Stellar is committed to pursuing this unmet medical need to make this diagnostic tool available to clinicians as quickly as possible, and will work to complete the development and regulatory activities identified during this meeting with the Agency.
About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) (www.StellarBiotechnologies.com) is a world leader in sustainable manufacturing of pharmaceutical grade immune carrier proteins (ICP), particularly with regard to the present most important pharmaceutical protein in this class, KLH (Keyhole Limpet Hemocyanin). This evolutionary protein has a highly complex structure that makes it ideal for use in human and animal vaccines and diagnostic products. With partners and customers, its flagship Stellar KLH products are in the clinic, and on the way to being established as the only sustainable, long-term pharmaceutical source.
There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on such statements. Except in accordance with applicable securities laws, the Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company's securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of these releases.
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