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Thursday, January 05, 2017 12:25:37 PM
"said the FDA will accept its approach to showing safety and efficacy using data drawn from previous studies. The regulator said benznidazole is expected to be eligible for a priority review voucher, which is given to sponsors of treatments for certain neglected tropical diseases. "This guidance makes it clear that we are on the right track with our development of benznidazole for Chagas disease, and we expect we will progress expeditiously toward a submission"
http://www.marketwatch.com/story/kalobios-stock-jumps-on-news-of-positive-guidance-from-fda-on-rare-disease-drug-2017-01-05
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