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Marshall Edwards Announces FDA Approval of Investigational New Drug Application for Lead Candidate ME-143
Date:8/16/2011

st and most advanced is a NADH oxidase inhibitor program that includes lead candidate ME-143 (formerly NV-143). The second is a mitochondrial inhibitor program that includes lead candidate ME-344 (formerly NV-344). The Company expects to initiate a Phase I clinical trial of intravenous ME-143 by September 2011 and submit an Investigational New Drug application for ME-344 by the first quarter of 2012. For more information, please visit www.marshalledwardsinc.com.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions
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