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Further development of this product is poised to resume after the lifting of a hold by the FDA. Prior to the initiation of any human clinical studies using Oxycyte in the US, the company will need to develop an FDA approved protocol which will incorporate FDA input on the design and safety measures to be utilized in such studies. Oxygen has been enrolling patients outside of the US in a Phase II-b study to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI). The study was recently enrolling patients in Israel for the second cohort of a three cohort trial.
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