It's not FDA who's asking to cut short of the steps. It's the Data monitoring committee who are a team of individuals expert in the field but outside the company who review data periodically. Their primarily goal is to review toxicity and adverse events associated with the patients and make recommendations to the company. Basically like Traffic police who gives green signal or red signal. They have suggested to cut short the number of patients based on the current data but the company will have to decide what to do. They have to review what they have promised the regulators in their initial submission. Also when the company designed the trial, they would have taken statistical considerations while choosing the number of patients to show statistical significance. So in order to cut short the trial, they have some thinking to do.
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