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PURE Bioscience Receives FDA Interim Safety Determination Authorization to Test Higher Concentrations of SDC-Based PURE Control® Antimicrobial as a Poultry Processing Aid
PURE Bioscience Receives FDA Interim Safety Determination Authorization to Test Higher Concentrations of SDC-Based PURE Control® Antimicrobial as a Poultry Processing Aid.
About this update from Pure Bioscience
[{"type":"text","content":"\n \n PURE Bioscience, Inc. (OTCQB: \n PURE), creator of the non-toxic, patented silver \n dihydrogen citrate (SDC) \n antimicrobial, today announced the Company had received a Preliminary \n Notification (PNC) authorization letter from the U.S. Food and Drug \n Administration (FDA) granting permission to conduct in-plant poultry \n processing trials at higher concentrations of the SDC-based PURE \n Control® antimicrobial to dramatically reduce Salmonella \n and Campylobacter.\n \n \n PURE has submitted the PNC to the USDA seeking permission to promptly \n begin poultry plant trials using up to 200 PPM of PURE Control.\n \n \n \n SDC is a non-toxic intervention that in testing has demonstrated \n superior reductions in a wide range of pathogens, including Salmonella \n and Campylobacter, during poultry processing.\n \n \n The pending USDA poultry processing trials (estimated to begin by the \n end of calendar Q1 ’17 with results reported before the end of \n calendar Q2 ’17), will evaluate PURE Control applied as a spray to \n whole chicken carcasses during Online Reprocessing and Offline \n Reprocessing.\n \n \n \n Once approved and commercialized, poultry processors will be able to use \n PURE Control in place of the highly toxic interventions currently being \n used.\n \n \n Pending trial results that are satisfactory to the USDA, and the \n issuance of a “No Objection” letter, PURE anticipates the final steps to \n commercialization of PURE Control for poultry processing to include:\n \n \n \n Receipt of an Acknowledgement Letter from the FDA that its FCN (Food \n Contact Notification) for use of SDC as a raw poultry processing aid \n at higher concentrations is complete, setting an effective date in May \n ’17 (the end of the FDA’s statutory 120-day review period).\n \n \n With USDA and FDA approvals in hand, PURE can begin to immediately \n commercialize PURE Control for US poultry processing into this new \n +$350m annual market.\n \n \n It is anticipated that the plant trial processors will be among the \n first customers for PURE Control for poultry processing.\n \n \n \n Hank \n R. Lambert, CEO, said that, “As soon as we complete the regulatory \n process to gain approvals for use of SDC throughout poultry processing, \n we are poised to begin commercialization into this i...