AspenBio Pharma
APPY, an in vitro diagnostic company, today provided its
shareholders and the broader investment community with an update on its
clinical and business activities. The Company announced that it plans to
initiate a pivotal study in the fourth quarter of 2012 for its blood-based
appendicitis test designed to assist emergency room clinicians in ruling out
acute appendicitis. The Company is moving ahead with its plans following its
recent productive meeting with the U.S. Food and Drug Administration ("FDA").
In addition to seeking approval in the U.S., the Company plans to obtain CE
Mark before the end of the year and to introduce the product in Europe shortly
thereafter.
Steve Lundy, President and CEO of AspenBio, stated, "We are very pleased with
the recent progress we have made in executing on our key development
objectives. Most importantly, after meeting with the FDA, we plan to initiate
our pivotal study in the U.S. during the fourth quarter. We are currently
modifying the study protocol in accordance with the FDA's constructive
feedback, and we continue to engage hospitals across the U.S. for
participation in our study. In parallel, we are preparing to launch the
product in Europe once we obtain a CE Mark, which we anticipate receiving
during the fourth quarter."
In addition to the Company's clinical advancements, AspenBio announced that
progress continues for its out-licensed animal health assets. To date,
cumulative consideration achieved under the exclusive license agreement is
approximately $1.3 million, including license fees and milestone payments
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in