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It represents a precautionary approach given limited long-term data rather than a response to documented concerns

Appropriate candidates for this treatment include people with classic TN pain in whom medications are ineffective or not tolerated, individuals with atypical features or with a diagnosis of trigeminal neuropathy, and individuals who are not deemed to be surgical candidates after review with the neurosurgical team

Evidence-gap matrix: what FDA evaluated and why uncertainty remained This matrix also explains how a favorable advisory vote can coexist with a negative staff recommendation

I am not convinced the data is fully there yet. Tatem said he expects the hearings to be a hard-fought battle, but hopes committee members will consider what he described as real-world data from tens of millions of doses administered between 2014 and 2023

possibly related to NO-mediated vasodilation