AspenBio Pharma’s AppyScore Test to conclude by March 31 (NASDAQ:APPY)

On February 9, 2010, AspenBio Pharma, Inc. (NASDAQ:APPY), which is a growing bio science company that develops innovative tests and drugs for the betterment of mankind, disclosed information about the Premarket Notification 510(K) that it had submitted to the United States of America’s toughest regulator the Food & Drug Administration. The 510(K) was submitted to get the FDA’s approval of using of its ELISA format AppyScore™ test for treating patients with acute appendicitis. In order to convince the FDA to approve its application, the company has been conducting a supplemental clinical trial on the AppyScore Test – the results of which it planned to send to the FDA. Already a total of 600 patients had participated in the trial. However, AspenBio Pharma thinks that this number is not enough – as confirmed by its “statistical” sizing method; so, it plans to enroll another 200 patients into the trial. As a result, the company does not expect to complete the trial before March 31, 2010.

Since a lot of time will be needed to analyze the data from the trial after its completion, the company decided that there is no need to keep its 510(K) submission pending during this time. As a result, it withdrew its submitted 510(K) application and plans to submit a new 510(K) application only when results from the supplementary trial are available. If approved by the FDA, AppyScore test would be the first test of the blood that can diagnose whether patients are suffering from acute appendicitis.

Previously, AspenBio Pharma has used an analysis of the data received before the supplementary trial and the information from several clinical experts, who have been hired by the company’s regulatory consultants, to draw up the Statistical Analysis Plan (SAP) for the ongoing trial. The plan specifies when the trial is going to end and what objectives it should achieve. However, the SAP provides only an “interim analysis” of the results achieved from the trial so far.

After the news of the withdrawal of the 510(K) submission was released, Daryl J. Faulkner, who is the company’s CEO, said:

“We believe AppyScore has the potential to help improve physicians’ evaluation of appendicitis, eliminating unnecessary CT scans and reducing radiation exposure risk for patients — while also reducing health care costs. We continue to actively enroll patients in the ongoing clinical trial and believe that submitting a new 510(k) based on a full analysis of the data from this study will provide the most effective path to 510(k) clearance. Our new timeline includes finalizing the trial results and submitting the new 510(k) in the second quarter of 2010.”