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After completing the phase 3 efficacy trial in August 2025, Moderna reported that it held a presubmission meeting with CBER and received written feedback requesting additional supportive analyses on the comparator and noted this would be a significant issue during BLA review
Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting acetaminophen and codeine phosphate tablets or when the dosage is increased, and that it can occur even at recommended dosages
Final purified proteins were lyophilized and stored at 80 C until use
FFA, free fatty acids
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