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AspenBio Plans to Initiate Pivotal Study in Q4


AspenBio Pharma (Nasdaq: APPY), an in vitro diagnostic company, today 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 ("FDA").  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.

Steve Lundy, President and CEO of AspenBio, stated, "We are very pleased with the recent progress we have made in executing on our key development objectives.  Most importantly, after meeting with the FDA, we plan to initiate our pivotal study in the U.S. during the fourth quarter.  We are currently modifying the study protocol in accordance with the FDA's constructive feedback, and we continue to engage hospitals across the U.S. for participation in our study.  In parallel, we are preparing to launch the product in Europe once we obtain a CE Mark, which we anticipate receiving during the fourth quarter."

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 $1.3 million, including license fees and milestone payments

Posted-In: News FDA


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