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News Breaks
September 27, 2012
07:30 EDTAPPYAspenBio Pharma plans to initiate pivotal study in Q4 following FDA meeting
AspenBio Pharma provided its shareholders and the broader investment community with an update on its clinical and business activities. The Company announced that it plans to initiate a pivotal study in the fourth quarter of 2012 for its blood-based appendicitis test designed to assist emergency room clinicians in ruling out acute appendicitis. The Company is moving ahead with its plans following its recent productive meeting with the U.S. Food and Drug Administration. In addition to seeking approval in the U.S., the Company plans to obtain CE Mark before the end of the year and to introduce the product in Europe shortly thereafter. In addition to the Company's clinical advancements, AspenBio announced that progress continues for its out-licensed animal health assets. To date, cumulative consideration achieved under the exclusive license agreement is approximately $1.3M, including license fees and milestone payments.
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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.
August 8, 2014
06:02 EDTAPPYVenaxis to host conference call
Conference call to discuss the progress of the APPY1 FDA submission will be held on August 11 at 8:30 am. Webcast Link

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