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Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data
Date:10/13/2008

ependent Data Safety Monitoring Board (DSMB) that will examine futility as well as safety. This constitutes a "go, no-go" decision point for the Viprinex clinical program. Passing the futility analysis would indicate that the drug has met predetermined interim efficacy criteria.

Because full enrollment of the consolidated trial is expected to be completed in the first quarter of 2009, NTI will not perform a superiority analysis during the interim review, in order to avoid taking a significant statistical penalty at the conclusion of the trial. Performing the interim futility analysis as planned does not carry any statistical penalty.

"We are very excited that after more than four years of hard work on our stroke program, we are rapidly approaching these two major milestones," stated Warren W. Wasiewski, M.D., vice president and chief medical officer. "Along with the rest of the stroke-care community, which has few treatment options at its disposal, I look forward with great enthusiasm to both the DSMB recommendation and the results of trial's final analysis."

Conference Call Details

NTI will hold a conference call to discuss this development later today at 1:00 p.m. (ET), 10:00 a.m. PT. The dial-in number is 877-440-5803 in the U.S. & Canada and 719-325-4942 elsewhere in the world. A telephonic replay will be available from 1:00 p.m. ET on October 13, 2008 to midnight ET on October 20, 2008. The replay number is 888-203-1112 in the U.S and Canada and 719-457-0820 elsewhere. The pass code is 9164451 for the conference calls.

About the Current Viprinex Stroke Trials

The ongoing Phase 3 clinical studies are designed to assess the efficacy and safety of Viprinex for the treatment of acute ischemic stroke when initiated within six hours of stroke onset. The studies are randomized, double-blind, placebo-controlled trials. Approximately 145 clinical sites are open to enroll patients into the trials in 14 countries.

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SOURCE Neurobiological Technologies, Inc.
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