More woe for AspenBio with new AppyScore delay
This article was originally published in Clinica
Executive Summary
AspenBio Pharma's 510(k) application for its troubled appendicitis blood test, AppyScore, looks likely to be delayed again. The company recently finished an expanded pivotal trial and had hoped to file the product with the US FDA in late June. However, it has now reported that it needs to carry out further analysis of the study results, as there was "unexplained variability" between sites. As a result, the Castle Rock, Colorado firm's share price on Nasdaq dropped by 54% on 7 June, closing at $1.57. This is not the first delay for AppyScore: AspenBio first submitted a 510(k) application in July 2009 based on disappointing results from a previous pivotal trial, but had to withdraw it in February and expand the study (www.clinica.co.uk, 10 February 2010).