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Antibiotic Development: Where Wall Street Guidance Is Watching FDA Guidances

 
• By Laura Helbling

FDA's effort to create a clearer path for antibiotic development has produced a series of new guidance documents. Those guidances are making some products in development look well-positioned for regulatory review, and rekindling the interest on Wall Street in specialty antibiotic firms. This article first appeared in the May 2011 issue of The RPM Report.

Trius Therapeutics Inc. is carrying an interesting new message to investors: the antibiotic approval criteria have changed at the Food and Drug Administration and the change has put one of its lead products (torezolid) onto a good path for approval review.

The company's frequent presentations on the financial meeting circuit highlight how FDA's new guidances in anti-infective development – specifically the...

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