Medical Letter on the CDC & FDA
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC & FDA
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. Reports on FDA Meeting, Next Oxycyte Clinical Trial and Development Direction
November 9th, 2008
Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) announced that it had a very fruitful and productive scientific meeting with the FDA to discuss the safety and development of Oxycyte(R) in Traumatic Brain Injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier. The company has subsequently decided to expand its research plan to include a sequential dose escalation safety and efficacy study of up to 40 patients. Due to the slight redesign of the protocol and administrative processes, patient enrollment is anticipated to begin in the first quarter of 2009. The company intends to conduct the study in the U.S. with a second study planned in Canada....
Source: Medical Letter on the CDC & FDA (2008-11-09)
|