Oxygen Biotherapeutics, Inc. (OTCBB: OXBO) announced that it has a meeting scheduled for October with the Food and Drug Administration (FDA) about any remaining issues with a planned trial for its Oxycyte drug.
Oxycyte is a perfluorocarbon oxygen carrier. Its proposed use is to help with traumatic brain injury. Oxygen Bio and the FDA, the U.S. medical standards agency, have tentatively set Oct. 20 as the meeting date.
“At that meeting, we will be extensively prepared to resolve any remaining issues and concerns the FDA may have,” said company Chairman and CEO Chris J. Stern. “We view this as a positive development, as the agency has also offered to review the Company’s overall development plan. This may contribute to reducing regulatory risk at future stages such as Phase III.”
Trials would be in the Phase 2b stage. The company would conduct a multi-center, double-blind, placebo-controlled study of up to 300 patients. 200 patients will be allowed for enrollment through a Department of Defense $1.9-million grant to the University Of Miami Miller School Of Medicine, Neurosurgery department.
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