So, the FDA asked us to stop enrolling EIND patien
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Posted On: 06/05/2020 1:30:25 PM
So, the FDA asked us to stop enrolling EIND patients and then relaxed the inclusion criteria for the trials. Anyone still doubt that the FDA is working WITH us?
I am confident that the severe/critical trial is going to be an overwhelming success. I believe that we will get a quick approval for this population. I am less confident about the mild to moderate as it is a more complicated calculus. FDA may ask for a Ph3 trial. But, as I have said before this would enroll quickly IMO because Leronlimab will be a household name once we have an approval.
I am confident that the severe/critical trial is going to be an overwhelming success. I believe that we will get a quick approval for this population. I am less confident about the mild to moderate as it is a more complicated calculus. FDA may ask for a Ph3 trial. But, as I have said before this would enroll quickly IMO because Leronlimab will be a household name once we have an approval.
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