AspenBio Pharma’s Meeting with FDA anticipated Soon (NASDAQ:APPY)

On December 29, 2009, 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. The pharmaceutical company also disclosed that it plans to hold a meeting with the FDA by no later than January 31, 2010 to talk about the submitted Premarket Notification 510(K) and to find out what other information the FDA needs to approve AppyScore test for clinical use. 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.

@@CalendarRight@@ AspenBio Pharma Inc is also conducting a supplementary clinical trial on the AppyScore test. At present, more than 400 patients have participated in the trial, and the number is increasing every day. These participants have been hospitalized in the emergency departments of several reputable hospitals in the USA.

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.

@@AdsenseLeft@@ According to the company, the SAP provides only an “interim analysis”. The SAP would be crucial for AspenBio Pharma in its meeting with the FDA in late January. This is because it would provide hints on the total sample size (that it, the total number of participants in the clinical trial) that would be required to meet all the objectives of the SAP. Such information is undoubtedly mandatory for inclusion in the Premarket Notifical 510(K) and also beneficial to physicians. The company had chosen to have 400 participants in the supplementary trial to make a correct decision on the “final sample size needed”, though it had initially planned to have only 250 patients. The company hopes that it would be able to complete the analysis by late January( that is, before its meeting with the FDA).

The company promised that it would give its stockholder an update on the required sample size and other information on the Premarket Notification 510(K) after meeting with the FDA and completing the “interim data analysis”.

Dr. Robert Caspari, who is the Chief Operating Officer and also the Chief Medical Officer of AspenBio Pharma Inc., said:

“We have received a clear message from our outside clinical experts, which is supported by our Medical Advisory Board, that the clinical value of AppyScore will be significantly enhanced by data that demonstrate that AppyScore achieves a negative predictive value substantially higher than current diagnostic modalities when used in conjunction with other commonly ordered diagnostic tests. We believe that taking the steps necessary to accomplish this objective will be well worth the time and costs and will result in added value.”