Nile Therapeutics, Inc. Adds to Executive Manag...(e difficult to gain U.S. Food andDrug Ad...)

Date:9/21/2007

e difficult to gain U.S. Food and Drug Administration, or FDA or other regulatory approval of our drug product candidates; risks that the FDA or other regulatory authorities may not accept any applications we file; risks that the FDA or other regulatory authorities may withhold or delay consideration of any applications that we file or limit such applications to particular indications or apply other label limitations; risks that, after acceptance and review of applications that we file, the FDA or other regulatory authorities will not approve the marketing and sale of our drug product candidates; risks relating to our own drug manufacturing operations and the drug manufacturing operations of our third-party suppliers and contract manufacturers; risks relating to the ability of our development partners and third-party suppliers of materials, drug substance and related components to provide us with adequate supplies and expertise to support manufacture of drug product for initiation and completion of our clinical studies; risks relating to the transfer of our manufacturing technology to third-party contract manufacturers, and the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten our ability to continue as a going concern.

Pharmaceutical and biotechnology companies have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. Data obtained from such clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. Except to the extent required by applicable laws or rules, we do not undertake to update any forward-looking statements or to publicly announce revisions to any of our forward-looking statements, whether resulting from new information, future events or otherwise.

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SOURCE Nile Therapeutics, Inc. Copyright©2007 PR Newswire. All rights reserved

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