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Biotech / Medical : GNBT Generex
GNBT 0.00Jan 27 4:00 PM EST

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From: Doc Bones2/13/2006 8:49:26 AM
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7:16AM Generex Biotech completes positive pre-IND meeting with FDA for its Avian Flu vaccine

(GNBT) 1.41 : Co announces that on Feb 10, 2006, Antigen Express, its wholly owned immunotherapeutics subsidiary, concluded a positive Pre-Investigational New Drug Application meeting with the FDA regarding plans for the commencement of clinical trials of the proprietary and innovative 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 innovative vaccine. Prior to the submission of its I.N.D, Antigen Express will conduct a toxicology study and a pre-clinical study to establish the vaccine's dosing regimen.
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