You really pulled out the most important info from
Post# of 154959
(Total Views: 677)
Posted On: 07/31/2020 10:54:02 AM
You really pulled out the most important info from the call, thanks. My opinion for why have the meeting is because if they did not and we were all sitting around for another 2 weeks with no data we would be assuming something must be wrong. I think Nader felt it necessary to update and temper expectations. The big achievement is their statements that the data is good, it just needs to be formatted and organized correctly. As much as we knew Leronlimab works, we now know that is more than just assumption or blind faith.
As for the degree of the symptoms and why it is now looked at in 3 phases vs 2, I think the FDA really did not know how to categorize this when the protocols were being set. We now know there are patients bad enough to go to the hospital but will recover, patient that need the hospital and will get worse and patients that are in really bad shape and on a ventilator likely to die. Pulling the data collected to see how Leronlimab helps speed up recovery, stop the worsening that leads to needing a ventilator and help those on ventilators get off them and recover is going to be really interesting. All other treatments are still cherry picking some part of this disease that they help on, not like Leronlimab that helps in such a broad range of patient condition. This trial data is going to be huge.
As for the degree of the symptoms and why it is now looked at in 3 phases vs 2, I think the FDA really did not know how to categorize this when the protocols were being set. We now know there are patients bad enough to go to the hospital but will recover, patient that need the hospital and will get worse and patients that are in really bad shape and on a ventilator likely to die. Pulling the data collected to see how Leronlimab helps speed up recovery, stop the worsening that leads to needing a ventilator and help those on ventilators get off them and recover is going to be really interesting. All other treatments are still cherry picking some part of this disease that they help on, not like Leronlimab that helps in such a broad range of patient condition. This trial data is going to be huge.
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