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(PubMed) Ho MJ, Li EC, Wright JM

doi: 10.1016/j.cmet.2014.01.018 66 GrahamTEYangQBlherMHammarstedtACiaraldiTPHenryRRet al

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A determination of clinical need is based on patient safety and medical necessity under the law

its absence is informative but not disqualifying, especially when mechanistic and physiological evidence is otherwise robust ( Finally, insurmountable technical barrierssuch as inability to manufacture stable formulations, extreme immunogenicity, or lack of feasible delivery routesmay justify abandonment independent of biological plausibility