Biopharmaceutical company AspenBio Pharma, Inc. (APPY) Friday announced the receipt of a request from the U.S. Food and Drug Administration, or FDA, for additional information related to the company's Premarket Notification 510(k) application for its AppyScore test filed in late June 2009.
The AppyScore test is the first blood-based test designed to aid in the diagnosis of human appendicitis.
The company said that it is continuing to evaluate the FDA request. The company also believes that it will be able to submit the additional data and information within the time period allowed by the FDA and within the schedule previously disclosed by the company, namely in the first quarter of 2010.
According to AspenBio, its management had determined in advance of the 510(k) application filing that the FDA may request additional data and information. The company had proceeded with certain additional analyses and testing, including supplemental trial work to ensure an efficient and timely response. This additional analysis and testing was begun in parallel with the FDA's initial review and the implementation of the study is proceeding as planned, the company noted.
APPY closed Thursday's trading at $2.40, up $0.08, on a volume of 54,600 shares.
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