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FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta™
Date:11/1/2010

addition, the FDA identified resolution of manufacturing issues related to recent site inspections at Hyaluron, Inc. and Wockhardt, Ltd. as a requisite for approval.

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward.  We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes."

Biodel's senior management will host a conference call today to discuss the CRL.8:15 am EDT:

Conference call participants should dial: +1 (877) 303 - 8028 (United States) or +1 (760) 536 - 5167 (International) 8:30 pm EDT:

Conference call begins About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. Biodel's product candidates are developed using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs.  Linjeta™ is Biodel's most advanced product candidate, which has been reviewed by the FDA and issued a complete response letter.  Earlier-stage product candidates include VIAtab™, a sublingual tablet formulation of insulin, a line of basal insulins, and a stabilized formulation of glucagon. For further information regarding Biodel, please visit the company's website at www.biodel.com.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements include statements about future activities related to the complete response letter regarding the company's new drug application for Linjeta™; the company's response to the complete resp
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SOURCE Biodel Inc.
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