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Avian Influenza
Positive pre-IND meeting with U.S. FDA for avian flu vaccine completed by Generex
March 24th, 2006
Generex Biotechnology Corp. (GNBT) announced that on February 10, 2006 Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, concluded a positive pre-investigational new drug application (IND) meeting with the U.S. Food & Drug Administration (FDA) regarding plans for the commencement of clinical trials of the Antigen Express vaccine to protect against the H5N1 avian influenza. As a consequence of the pre-IND meeting, Antigen Express has clarified the development path (including clinical study design) and regulatory timetable for its vaccine. Prior to the submission of its IND, Antigen Express will conduct a toxicology study and a preclinical study to...
Source: Drug Week (2006-03-24)
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