AspenBio Pharma Inc reported today that the company is performing additional data analysis on its recently completed pivotal clinical trial. As a result, the submission of its 510(k) application for AppyScore with the FDA will not occur as previously anticipated by late June 2010.
The company has determined that additional data analysis is necessary, as there was unexplained variability in results from site to site in the initial draft of the statistical analysis report. The continued analysis of these data and related work is AspenBio’s highest priority and, upon completion, the Company will provide additional information.
"There is significant variability among clinical sites that we must reconcile to fully understand the results," said Steve Lundy, AspenBio Pharma’s president and CEO. "Our commitment is to conduct a rigorous data analysis and we will report on this analysis as soon as we are able."
Source: AspenBio Pharma