I think we overlook this important fact about Prurisol. Phase 2b was for increased dosing efficiency. 200mg was a success and 300mg may be even better. Not sure where 400mg takes us . Either way we WILL see a Phase 3 study, it will be quick and it will reflect off Ziagen’s FDA approval. Ziagen is taken in 300mg doses twice a day. I am expecting to see the best bell curve at 300mg for Prurisol.
About 505(b)(2) Development Approach
Under the FDA’s 505(b)(2) development approach, a drug candidate’s road to market approval can be significantly shortened and conducted at a much reduced cost. Long-term safety data from a reference drug may be relied upon for approval, and potentially only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required to establish drug efficacy. For more information about the FDA’s 505(b)(2) development program, please visit: http://www.fda.gov/downloads/Drugs/…/Guidan...079345.pdf
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