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New Drug Application (NDA): If clinical trials demonstrate that the drug is safe and effective, the sponsor submits an NDA to the FDA, which includes all data from the trials, labeling information, and manufacturing details

For example, the baseline characteristics of the first 99 patients hospitalized in Wuhan found that 6% had an elevated activated partial thromboplastin time, 5% showed elevated prothrombin and 36% had elevated D-dimer 6

The treatment for 24 weeks led to substantial reductions in liver fat content across all dosage levels, with a mean relative change from baseline of up to -82.4% for the highest dose

Understanding these limitations helps set realistic expectations and encourages more cautious decision-making, which ultimately reduces risk