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At the time, the FDA presented a lot of adverse event data that showed there was a risk of immunogenicity immune reactions and that raised some red flags for the committee, said Gupta, an adjunct assistant professor of anesthesiology at the Johns Hopkins University School of Medicine

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Mechanistically, our work reveals a consecutive and mutually exclusive binding of both MetAPs and NMT1 at the tunnel exit, rather than a stable multi-enzyme complex

FDA guidance on RUO and IUO labeling explains that research labeling is tied to the research phase and should not be represented as diagnostic positioning [20], [21]

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