- Minutes received from recent FDA meeting on benznidazole
- 505(b)(2) regulatory pathway using existing safety and efficacy data is acceptable
- Benznidazole eligible for neglected tropical disease priority review voucher
- KaloBios to present company update at Biotech Showcase™ 2017
- The company's proposed 505(b)(2) approach to demonstrate safety and efficacy using some data drawn from previously conducted studies is acceptable to FDA.
- If approved as a treatment for Chagas, benznidazole is currently expected to be eligible for a priority review voucher (PRV), awarded to sponsors of certain treatments for neglected tropical diseases that meet criteria specified by the Federal Food, Drug, and Cosmetic (FD&C) Act.
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