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Article: FDA Lifts Clinical Hold on Oragenics' Novel Treatment for Prevention of Dental Caries; Company Anticipates Beginning Phase I Study of Replacement Therapy in Early 2005.
- Article from:
- Business Wire
- Article date:
- November 30, 2004
CopyrightCOPYRIGHT 2004 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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ALACHUA, Fla. -- Oragenics, Inc. (AMEX:ONI) reported today that the U.S. Food and Drug Administration (FDA) has agreed to lift the clinical hold on the company's Replacement Therapy for the treatment of dental caries. The FDA's clearance to proceed with a Phase I safety trial came following the agency's completed review of the study's clinical design and the unanimous vote of the Recombinant DNA Advisory Committee (RAC) on March 15, 2004, that the first human clinical study of Oragenics Replacement Therapy be carried out under the protocol proposed by the company. The FDA had placed Oragenics' original Investigational New Drug application (IND) on clinical hold in May ...