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SIGA Submits Pivotal Animal Final Study Reports to FDA; Actions Achieve Critical BARDA Milestone; Company Now Eligible for $20.5 Million Payment

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SIGA

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Additional Relevant Details Siga Technologies has received approval from its Data Safety Monitoring Board (DSMB) to complete enrollment in the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX (tecovirimat), for the treatment of orthopoxvirus infections. This determination was based on review of safety data from the first 125 participants in the final cohort. The final cohort of this Phase III study is being conducted at eleven approved clinical investigation sites in a total of approximately 380 subjects.The initial Phase III cohort of 40 subjects in this trial was completed in 2015 without any reports of serious adverse events. Since TPOXX™ (tecovirimat) is being developed under the FDA "Animal Rule," there are only safety and not efficacy endpoints in this clinical trial. This Phase III study is wholly funded by the Biomedical Advanced Research and Development Authority (BARDA).SIGA also announced that it has submitted its final pivotal animal study reports to the Food and Drug Administration (FDA). As a result of both the DSMB decision and the submission of the FDA animal final study reports, SIGA is eligible for a milestone payment from BARDA of $20.5 million.
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Catalyst Date
Occurred on:
Aug 08, 2016
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Related Keywords Tpoxx, Tecovirimat, Barda Milestone, Orthopoxvirus Infections