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Safety and pharmacokinetics of intravenous and oral fosmanogepix, a first-in-class antifungal agent, in healthy volunteers

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Bouligny I, Montalban-Bravo G, Sasaki K, Daver N, Jabbour E, Alvarado Y, DiNardo C, Ravandi F, Borthakur G, Bose P, Pemmaraju N, Kornblau S, Kadia T, Masarova L, Takahashi K, Andreeff M , Kanagal-Shamanna R, Hosing C, Pierce S, Meyer M, Huang X, Kantarjian H, Garcia-Manero G

Most LDTs are expected to require a 510(k) or de novo , but if the type of submission is unknown, the regulatory pathway/strategy should first be determined