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AspenBio Pharma Reports Second Quarter 2007 Results
Date:8/20/2007

inally anticipated to complete, this has allowed us to fine tune specific aspects of blood collection as well as the practical use of the test in a hospital clinical setting. The company is currently engaged with multiple hospital sites for the collection of additional trial samples.

AspenBio has also commenced initial steps for the U.S. FDA approval process for AppyScore with the engagement of three widely recognized FDA device registration consultants to assist with the process. The company expects an initial meeting with the FDA on the AppyScore Appendicitis Triage Blood Test to occur within the next thirty to forty-five days. AspenBio has also executed contracts with FDA-approved diagnostic test manufacturers related to assay development, GMP manufacturing, and validation of different versions of the first generation AppyScore and AppyScreen test formats. The on-going 400 patient pre-FDA trial is anticipated to be completed by the end of September, with an announcement of the data planned shortly after completion. These activities, if successfully completed, put the first generation of AppyScore on a timeline for introduction in the United States in 2008.

BoviPure FSH: AspenBio Pharma announced in July it had filed and received an INADA file number for BoviPure FSH (bovine follicle stimulating hormone) to officially start the FDA approval process. Additionally, in order to facilitate the product advancement, AspenBio also executed a contract with AppTec Laboratory Services, Inc. ("AppTec") for the required GMP manufacturing and validation of this product. This advancement follows a similar path that commenced in January for StayBred(TM) (a/k/a BoviPure LH(TM), an LH analog for cows), AspenBio's largest market potential, single-chain, reproduction- enhancing drug.

BoviPure FSH, the company's second largest market potential livestock drug, is currently advancing ahead of schedule with the initiation of the FDA approval process. This drug is desig
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SOURCE AspenBio Pharma, Inc.

Copyright©2007 PR Newswire.

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