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[10] FDA's assessment nonetheless found insufficient safety and efficacy data across all three nominated uses, and noted a route mismatch: the human studies used intravenous administration while the nomination proposed subcutaneous administration

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Neoplasia 9:111121, PMID: 18084618 Hartnett L, Egan LJ (2012) Inflammation, DNA methylation and colitis-associated cancer

V.GettingS.et al (2022)

Key observation: All dose groups began at 0.5mg with gradual escalation over several weeks before reaching maintenance doses