Does Prurisol needs to do a Phase 3 trials assumin

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For a standard 505(b)(1) NDA, Phase III generally consists of two large, well-controlled studies (often referred to as pivotal studies) that include hundreds or even thousands of patients and are designed to produce statistically and clinically meaningful evidence of the product’s safety and efficacy. Once again, because a 505(b)(2) submission can rely in part on existing data, Phase III studies are often not necessary .

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