Posted On: 07/19/2016 10:10:57 PM
Post# of 72446
Does Prurisol needs to do a Phase 3 trials assuming Phase 2b is successful since it is following 505(b)(2) pathway??
http://camargopharma.com/what-is-505b2/
Quote:
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 .
http://camargopharma.com/what-is-505b2/
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