AspenBio Pharma, Inc. (AspenBio), has received FDA request to submit additional information regarding premarket notification 510(k) application for its AppyScore test filed in late June 2009. The test is intended for diagnosis of human appendicitis.
The company is evaluating continuously to submit the additional information within the time limit allowed by FDA and within the schedule previously disclosed by the company as Q1 2010.
AspenBio management has previously analyzed that the FDA will ask for additional information and data for 510(k) application filing (and in consultation with their regulatory consultants, Becker & Associates Consulting of Washington, DC). The company started to responded efficiently and in time, with certain additional analyzes and testing, including supplemental trial work. This additional analysis and testing was begun simultaneously with the FDA’s initial review and the implementation of the study is moving forward 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.