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In its Complete Response Letter, the regulator cited deficiencies in the companys clinical application

Early life disturbances such as premature birth, which can increase intestinal permeability, can also affect bone density [59]

After 24 h, 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (0.2 to 0.4 mol/l) and N-hydroxysuccinimide (0.4 to 0.6 mol/l) were added into the solution

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So far allogeneic CAR-T cells have not been able to persist in the body long enough to have the potent effects hoped for, and instead are rejected in just weeks