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[DOI] [PMC free article] [PubMed] [Google Scholar] 130.Kovoor J.G., Rayner C.K., Wu T., et al
Ill discuss this assumption in future posts.) In the absence of clinical trials demonstrating long term safety and health in a diet-vs-drug comparisonand assuming the two methods can be equally effective, which may or may not be true and would depend on a host of variableswere left with the question of which is safest
A plausible scenario, then, looks like this: Phase 3 primary completion in late 2025, NDA submission in the second half of 2025, FDA filing acceptance and review initiation in early 2026, and a PDUFA (Prescription Drug User Fee Act) action date likely in mid to late 2026
Some patients describe the pain as a sense of pressure or soreness, which can be managed with prescribed pain medications and plenty of rest
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