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Re: TheGreatSwami post# 7310

Wednesday, 08/30/2017 4:07:52 PM

Wednesday, August 30, 2017 4:07:52 PM

Post# of 42415
On August 29, 2017, the U.S. Food and Drug Administration announced that it had granted accelerated approval of a benznidazole therapy manufactured by another company for the treatment of Chagas disease, and had awarded the other manufacturer a tropical disease priority review voucher (PRV).

As a result of FDA’s actions and with the information currently available, Humanigen, Inc. no longer expects to be eligible to receive a PRV with its own benznidazole candidate for the treatment of Chagas disease. Accordingly, Humanigen is assessing its options in respect of that development program and the company’s monoclonal antibodies, lenzilumab and ifabotuzumab. https://www.sec.gov/Archives/edgar/data/1293310/000121465917005374/b8301708k.htm