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Targanta’s Noninferiority Study Design Could Be Regulatory Hurdle For Oritavancin

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Targanta may need to conduct additional clinical trials of its intravenous antibiotic oritavancin if FDA does not accept the company's use of a 15 percent noninferiority delta in its Phase III trial, according to the firm's initial public offering prospectus filed May 11 with the Securities & Exchange Commission.

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