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August 11, 2014
08:12 EDTAPPYVenaxis annonces regulatory and market development progress
Venaxis announced previously that its FDA submission for the APPY Test had been filed with the U.S. Food and Drug Administration and that the FDA had reviewed the submission and provided Venaxis with an Additional Information request. Under the FDA's Submission Issue Meeting procedure, Venaxis also requested clarification from the FDA on certain of its feedback contained in the AI request. Today, Venaxis is reporting the current status of its FDA submission. The FDA has clarified the scope of the additional data requested to complete the supplemental filing to the submission package. Venaxis is in the process of compiling these data, revising its submission to address the FDA feedback, and plans to fully comply with the FDA's AI request. Based on an initial analysis of the scope of work required to completely respond to FDA feedback, Venaxis anticipates submission of the supplemental filing in Q4 of this year.
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September 11, 2014
07:25 EDTAPPYAegis to hold a conference
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