Thursday, March 30, 2023 7:41:20 PM
So, according to the latest Press Release, "Although the Study was originally designed for a ‘hospitalization or death’ primary endpoint, and it completed enrollment of almost three-quarters of the Study’s recruitment goal and recorded specific clinical symptoms (i.e. cough, fever, heart rate, and oxygen saturation), the Study was not designed to take into account all of the symptom assessments and supporting data outlined in the FDA guidelines to warrant a primary symptom-based endpoint for COVID-19 studies."
Which is why they're unable to pivot to the FDA's recommended primary endpoint. Even though the design was for hospitalization they should have assigned it in order to take in all data points to be more thorough.
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