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Hyperion Therapeutics Receives Special Protocol Assessment Approval From FDA For Pivotal Phase III Trial In Urea Cycle ...
Published July 8, 2009, 10:15 am, Medical News Today
Hyperion Therapeutics announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the pivotal Phase III trial of investigational product HPN-100 (glycerol phenylbutyrate) in adults with urea cycle disorders (UCD).
Hyperion Therapeutics Receives Special Protocol Assessment Approval From FDA for Pivotal Phase III Trial in Urea Cycle ...
Published July 7, 2009, 5:00 am, Business Wire via Yahoo! Finance
SOUTH SAN FRANCISCO, Calif.----Hyperion Therapeutics today announced that it has reached agreement with the U.S. Food and Drug Administration under the Special Protocol Assessment process for the pivotal Phase III trial of investigational product HPN-100 in adults with urea cycle disorders .
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