Oxygen Biotherapeutics, Inc. to Submit Revised Protocol for Oxycyte(R) Clinical Trials in the U.S.A. and Canada… November 8, 2008
Posted by intebic in TBI Info.trackback
Oxygen Biotherapeutics, Inc. announced that it will submit an amended test protocol to the FDA and almost simultaneously in Canada to cover dose escalation studies of Oxycyte(R) in Traumatic Brain Injury (TBI). Oxycyte is the Company’s perfluorocarbon (PFC) therapeutic oxygen carrier. The company intends to file the amended protocol in global format, which allows for submission in the U.S. and other countries, within approximately 50 days.
Under the revised protocol, the company intends to enroll 40 TBI patients in each country…
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