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Napo Obtains Special Protocol Assessment Agreement From FDA for Crofelemer

planned after all subjects complete the 28-day efficacy period. A full study analysis and final study report will be prepared at that time that will form the basis of a subsequent New Drug Application (NDA) filing to FDA. Subjects who complete the efficacy part of the study will be allowed to continue into an open-label, five-month extension. The purpose of the extension is to provide additional safety and tolerability information about crofelemer in longer tem use.

Commenting on this announcement, Lisa Conte, Chief Executive Officer of Napo Pharmaceuticals, said: "The SPA agreement is an important milestone for Napo, allowing us to address and mitigate regulatory uncertainty prior to the completion of our final Phase 3 trial in support of the Company's first NDA filing, targeted for early 2008."

Dr. Scott Harris, Vice President, Clinical Affairs, and Chief Medical Officer, said: "Napo has taken every effort to design and execute a Phase 3 program with the highest possible probability of success, incorporating experience from approximately 1,500 patients studied in clinical trials involving crofelemer. Already, 55 patients have enrolled in a previously conducted Feasibility Study of CRO-HIV. We expect these patients to be immediately eligible for enrolment for the ADVENT study."


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