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Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adjuvant Patch
Date:4/15/2008

ng statements. Such forward-looking statements include statements about the ability of Iomai's adjuvant patches to provide protective immune responses with one or two doses of H5N1 influenza vaccine; the significance of the results described in this press release to government health officials in addressing an outbreak of pandemic influenza; that the clinical trial data from the new clinical trial will be sufficient to proceed next with a pivotal Phase 3 clinical trial; that the characteristics of Iomai's adjuvant patch described in this press release would make the product ideal for stockpile and rapid distribution; the anticipated reimbursement for the costs associated with further testing of the adjuvant the patch and the potential future funding authorized by HHS. Applicable risks and uncertainties include, among others, that future clinical trials may not replicate results seen in the trial described in this press release; that the U.S. Food and Drug Administration or other regulatory authorities may not concur with Iomai's analysis of the trial results described in this press release; that Iomai may not be able to enroll sufficient numbers of subjects in future clinical trials; that Iomai may be unable to obtain the regulatory approvals or financing necessary to conduct additional clinical trials, or to develop the product to a point where the adjuvant patch can be sold to the government for stockpiling for its pandemic influenza program; that competitors may develop products that are safer, more effective, or more convenient to use; future clinical results may not support regulatory approval to commercialize Iomai's adjuvant patch for pandemic influenza applications, which will depend on the outcome of additional clinical trials and analysis by regulatory authorities of data Iomai submits; that Iomai may not meet its contractual milestones in order to fully perform under the contract and thereby receive complete reimbursement from HHS; that Congress will not
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SOURCE Iomai Corporation
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