One key point Dr Javitt made on the recent RLFTF v
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Posted On: 02/12/2021 12:22:56 PM
One key point Dr Javitt made on the recent RLFTF video with Dr Yo was that trial monitors are not allowed in the hospital and not allowed remote access to health records - so they have to coordinate with hospital staff for any data follow up, which is taking more time than usual for data cleaning/checking etc.
I also believe we may be waiting for the 42 day data. Again, in the RLFTF video Javitt noted that the FDA’s use of 28 day mortality was an anachronism - and not selected specifically for the drug in trial. Which is why they are pursuing 60 day mortality data. This leads me to believe we are looking at the 42 day data - also based on the DSMB recommendation (albeit that was at the 75% point).
I also believe we may be waiting for the 42 day data. Again, in the RLFTF video Javitt noted that the FDA’s use of 28 day mortality was an anachronism - and not selected specifically for the drug in trial. Which is why they are pursuing 60 day mortality data. This leads me to believe we are looking at the 42 day data - also based on the DSMB recommendation (albeit that was at the 75% point).
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