Tuesday, novel proprietary drugs developer for humans and animals AspenBio Pharma, Inc. (APPY), announced positive results from the FDA clinical trial for AppyScore, and an update on pursuing market authorization in the U.S. The company said that it is the world's first blood-based test as an aid in the diagnosis of human appendicitis.
However, the stocks plunged 80% on Tuesday's trading after getting the news that the company is unlikely to bring ELISA test format to the market, and not confident about the FDA approval.
In the preliminary results, AspenBio Pharma has demonstrated the relationship between AppyScore and the risk of pathologically proven appendicitis in patients with acute abdominal pain. The reported results indicate that the negative predictive value using the previously suggested optimal threshold of AppyScore at 20 is 83% as compared to 96% - observed in the earlier pilot study. In particular when used in combination with a normal white blood count a negative predictive value of 98% was achieved using an AppyScore cut-point of 15.
Following the announcement, Richard Donnelly, president and CEO of AspenBio Pharma, said, "We are encouraged the data from this study continues to support our longstanding belief that AppyScore, in conjunction with other standard diagnostic approaches, could provide a significant improvement in the evaluation of abdominal pain. However, we do not know if the resulting data will be acceptable or sufficient for FDA clearance for our intended use until the FDA makes such determinations."
Along with our FDA consultants we are evaluating our next steps regarding an FDA pre-market notification submission to secure clearance as a diagnostic tool as an aid in the diagnosis of acute appendicitis, Donnelly added.
Additionally, the company said that it continues to develop AppyScore and the next generations of the appendicitis test. Based upon a current assessment, the company would unlikely to bring an ELISA test format to market, and bolster on development of compact reader and cassette version, which is a faster and low cost version.
APPY is currently trading at $1.28, loosing $6.35 or 83.22% on a volume of 4.9 million shares on the Nasdaq.
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