My thought is if this Mexico trial is the same pro
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Posted On: 06/29/2020 7:42:37 AM
My thought is if this Mexico trial is the same protocol as the severe trial, but with only 25 patients, why even do the trial? Couldn’t Mexico just look at the interim data from the 50+ patients in the FDA trial? If Mexico wants to save as much time as possible that would make sense. We do know many countries approve drugs based on US FDA trials without doing their own trials, so why is Mexico even doing this trial?
Maybe our hunch is right, it’s to not put all our eggs in one FDA basket. Maybe Mexico doing its own trial is just a precaution in case the fda trail drags on to long requiring all 390 patient enrollment?
Also, I was thinking about which trial or both Leronlimab gets approval for, does it really matter? Wouldn’t the doctor decide if a patient is mild or severe? If leronlimab is approved for mild cases, what is stopping a doctor from using it on more severe cases?
Maybe our hunch is right, it’s to not put all our eggs in one FDA basket. Maybe Mexico doing its own trial is just a precaution in case the fda trail drags on to long requiring all 390 patient enrollment?
Also, I was thinking about which trial or both Leronlimab gets approval for, does it really matter? Wouldn’t the doctor decide if a patient is mild or severe? If leronlimab is approved for mild cases, what is stopping a doctor from using it on more severe cases?
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