>>POZEN Receives Initial FDA Response To PA32540 SPA
Friday August 1, 4:05 pm ET
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News), today announced that the U.S. Food and Drug Administration (FDA) has provided an initial response to POZEN’s Special Protocol Assessment (SPA) for PA32540, which was submitted in June 2008. The company plans to meet with the FDA to discuss their responses to our proposed protocol for the Phase 3 pivotal studies, including the inclusion/exclusion criteria, the stratification plan, the primary endpoint, and the statistical methodology to be used in the study. The company also plans to discuss an additional pharmacodynamic study requested by the FDA which would support the bioequivalence study previously conducted for PA32540.
The SPA is a process by which the FDA and the company reach an agreement on the Phase 3 pivotal trial protocol design, clinical endpoints, and statistical analyses that are acceptable to support regulatory approval. An SPA is binding upon the FDA and the Sponsor unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun. For more information please visit the FDA website: www.fda.gov/CbER/gdlns/protocol.pdf. <<
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For some reason, this causing an AH sell off, ~9%. I haven't followed POZN lately. Anyone what the fly in this ointment is?
Cheers, Tuck |
