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PHASE II:Building on the Phase I effort, Phase II prototype development should demonstrate the systemic safety and therapeutic potential of the treatment/technology upon intravenous administration in appropriate models of traumatic hemorrhage in vivo. The focus of these studies would be to establish systemic safety, pharmacology/toxicology parameters and reduction in blood loss, prevention or alleviation of hypothermia, amelioration of acidosis and overall enhancement in survival. Phase II should also provide a detailed plan for practical implementation of the therapies at Point of Injury or en route care including dosage parameters (dosing limits, therapeutic window, etc). The submitter should assess and verify the Technology Readiness Level (TRL) of the proposed therapy at the conclusion of Phase II. The offeror will provide a clear regulatory plan on how they propose to achieve FDA clearance. Follow-on activities shall include the necessary studies requested by the FDA to gain clearance of the technology and/or drug for use in treatment of traumatic bleeding
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TOMBSTONE, N.M. (AP) A western New Mexico familys Thursday hunting trip into the mountains ended with a 7-year-old girl, a toddler and a woman who died in a crash that killed the father, officials said.
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