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The reasons fall into several distinct categories, and your specific reason shapes which alternative makes the most sense
Sequential Use vs
Limited Clinical Trials : If you are seeking a new indication (e.g., sleep apnea), the FDA will likely require a Phase 3 trial, but you can bypass the Phase 1 and Phase 2 safety stages, saving years and millions in capital
Eren-Yazicioglu, C
10.3389/fcell.2025.1558137 54 GersteinH
Although typically solitary, rare patients may present with multifocal lesions
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