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"While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocol-specified eligibility criteria before you enroll them into the study," said FDA

10.1016/j.expneurol.2010.02.006 26 BurgessJ.FerdousiM.GosalD.BoonC.MatsumotoK.MarshallA.et al (2021)

Identification and therapeutic modulation of a pro-inflammatory subset of disease-associated-microglia in Alzheimer's disease

27 Consistent with the lack of mitochondrial involvement, erastin did not cause ATP depletion, and morphologically, mitochondria appeared smaller and denser, but not swollen or ruptured as seen in classical necrotic cell death

Taken together, these findings suggest that DMF exhibits a strong immunomodulatory effect in pulmonary diseases