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Examples
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Each of the pivotal trials is a double-blind placebo-controlled study designed to evaluate the safety and efficacy of Pimavanserin in approximately 240 patients with PDP.
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We now have considerable clinical experience with Pimavanserin over a wide range of clinical trials involving over 500 subjects.
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As we advance our Phase III program toward completion of the first pivotal trial, we are pleased to see a growing level of interest in Pimavanserin on the part of potential partners.
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Patients receive oral doses of either Pimavanserin or placebo once daily for 6 weeks in addition to stable doses of their existing dopamine replacement therapy.
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Patients who have completed either of the Phase III trials have the opportunity to enroll in this study if in the opinion of their physician they may benefit from continued treatment with Pimavanserin.
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Our remarks today will focus largely on our Phase III program with Pimavanserin for Parkinson disease psychosis or PDP.
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To date, the exposure to Pimavanserin in this study equates to over 50 patient years.
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Pimavanserin tartrate is a selective 5-HT2A inverse agonist currently in a Phase III study for
GEN News Highlights 2009
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Clearly with the increasing safety data base on that we have with the proof of concept data from Phase II and an additional positive Phase III clinical trial, there is very little risk left in the program, and I think that at that point, if not sooner, we should be able to realize the kind of value that we expect from Pimavanserin to weigh partnerships.
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Our Phase III program in Pimavanserin for PDP continues to be the highest priority for the whole organization.
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