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Biodel Reports First Quarter Fiscal Year 2011 Financial Results
Date:2/3/2011

n in other income as a result of the revaluation.

Expenses for the three months ended December 31, 2010 and 2009 include $1.5 and $1.3 million, respectively in stock-based compensation expense related to options granted to employees and non-employees.

Biodel did not recognize any revenue during the three months ended December 31, 2010 or 2009.

At December 31, 2010, Biodel had cash and cash equivalents of $22.3 million and 26.4 million shares outstanding.  

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Biodel recently met with staff from the U.S. Food and Drug Administration (FDA) on January 28, 2011 to discuss the agency's October 29, 2010 complete response letter regarding the NDA for Linjeta™ and to explore appropriate next steps for the ultra-rapid-acting prandial insulin program.  The End of Review Meeting addressed questions posed by Biodel in response to the FDA's complete response letter.  During the meeting the FDA considered questions posed by Biodel to help define paths forward regarding clinical trial design, injection site tolerability, toxicology and chemistry, manufacturing and controls.

Since the Linjeta™ NDA was submitted in December 2009, Biodel has developed and tested new formulations of Linjeta™ that maintain its favorable pharmacokinetic profile for speed of activity and stability and may improve injection site tolerability.  Based upon encouraging early results from these studies, Biodel has decided to fund clinical development of several alternative formulations of Linjeta™ with the goal of determining the preferred formulation and advancing it into Phase 2 clinical testing in 2012.

The company has decided to focus most of its resources on the ultra-rapid-acting prandial insulin program and to limit funding of its earlier-stage development programs, which include a glucose-sensing basal insulin formulation, a glargine formulation with improved basal characteristics, a stable liqu
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SOURCE Biodel Inc.
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