Appendicitis - AspenBio Pharma 510(k) Filing For AppyScore Advances In FDA Review With Request For Additional Information

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 23 Aug 2009 - 0:00 PDT


AspenBio Pharma, Inc. (NASDAQ: APPY) reported it has received a request from the U.S. Food and Drug Administration ("FDA") for additional information related to AspenBio'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 is continuing to evaluate the FDA request, but believes 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 Q1 2010.

Management of AspenBio had determined in advance of the 510(k) application filing (and in consultation with their regulatory consultants, Becker & Associates Consulting of Washington, DC) that the FDA may request additional data and information. To ensure an efficient and timely response, the company had proceeded proactively with certain additional analyses and testing, including supplemental trial work. 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.

Dr. Robert Caspari, COO and CMO of AspenBio, noted: "We believe the data and information submitted in the AppyScore 510(k) is in compliance with applicable regulations. Nevertheless, we anticipated that like most 510(k) premarket notifications that require clinical data, the FDA's evaluation of our submission would likely result in one or more additional information requests. While there can be no assurance the additional information we provide will successfully address all of the FDA inquiries, we believe we are well positioned to do so."

Source
AspenBio Pharma, Inc.

• Additional
• References
• Citations