<br>        Patients must meet all of the following inclusion criteria to be considered for enrollment<br>        in this study:<br><br>          1. Male or female neonatal patient (1 to 28 days of age [inclusive] at the time of<br>             ORGN001 administration, with day 1 of age corresponding to the day of birth) or infant<br>             (29 days to <2 years of age) or child (2 to 5 years of age [inclusive]) with MoCD Type<br>             A, previously untreated with ORGN001 or treated with ORGN001 through the EAP<br><br>          2. In neonates, diagnosis of MoCD Type A, based on:<br><br>             Prenatal genetic diagnosis, or Onset of clinical and/or laboratory signs and symptoms<br>             consistent with MoCD Type A (eg, seizures, exaggerated startle response, high-pitched<br>             cry, axial hypotonia, limb hypertonia, feeding difficulties, elevated urinary sulfite<br>             and/or SSC, elevated xanthine in urine or blood, or low or absent uric acid in the<br>             urine or blood) within the first 28 days after birth<br><br>          3. In infants or children, diagnosis of MoCD Type A, based on:<br><br>             Confirmed genetic diagnosis (genetic confirmation of the diagnosis of MoCD Type A may<br>             be obtained after initiation of ORGN001 therapy in certain cases), biochemical<br>             profile, and clinical presentation consistent with MoCD Type A<br><br>          4. Parent or legal guardian must have signed the informed consent form (ICF) prior to any<br>             study procedures being performed<br><br>        Patients will be excluded from participating in the study if they meet any of the following<br>        criteria:<br><br>          1. Diagnosis other than MoCD Type A (may be determined after the initiation of study<br>             drug)<br><br>          2. Condition that is considered by the treating physician to be a contraindication to<br>             therapy, including evidence of abnormalities on brain imaging not attributable to MoCD<br>             Type A, or that might otherwise interfere with the patient's participation in the<br>             study, pose any additional risk for the patient, or confound patient assessments<br><br>          3. Antenatal and/or postnatal brain imaging prior to initiation of treatment with ORGN001<br>             that indicates cortical or subcortical cystic encephalomalacia, clinically significant<br>             intracranial hemorrhage, or other abnormalities on brain imaging determined by the<br>             treating physician to be clinically significant<br><br>          4. Modified Glasgow Coma Scale (mGCS) for Infants and Children score of less than 7 for<br>             more than 24 hours (does not apply to children less than 1 day in age).<br>