TransTech Pharma, Inc. Announces Agreement With FDA On Special Protocol Assessment For TTP488 Phase 3 Trial In Patients With Mild Alzheimer’s Disease
7/10/2014 10:21:12 AM
HIGH POINT, N.C.--(BUSINESS WIRE)--TransTech Pharma, LLC today announced that it has reached an agreement with the U.S. Food and Drug Administration Division of Neurology Products, under the Special Protocol Assessment (SPA) process, on the design of a single Phase 3 trial of TTP488 for the treatment of patients with mild Alzheimer’s disease. A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the Phase 3 trial design, planned execution and statistical analyses are acceptable to support regulatory approval. Additional information regarding the FDA’s Special Protocol Assessment process may be found at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080571.pdf.
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