Essentialis To Submit SPA For Hypertriglyceridemia
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Essentialis To Submit SPA For Hypertriglyceridemia
Essentialis, inc., a clinical stage pharmaceutical company, announced today its intention to file a special protocol assessment (spa) with the fda for the pivotal study to support the nda filing o
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Most Recently Shared on August 13, 2009 at 11:20 am By:
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Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides
news-medical.net — “Essentialis, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 efficacy study required for product registration for its product candidate, Diazoxide Choline Controlled Release Tablet (DCCR), for the treatment of patients with very high triglycerides.” View full resource at news-medical.net
Most Recently Shared on October 25, 2010 at 11:37 am By:
Essentialis, FDA enter agreement on SPA for DCCR Phase 3 efficacy study in patients with high triglycerides: Essen... http://bit.ly/dCs6HA
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