INTERESTED IDEA, TELL NADER: (stolded stold stee
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Posted On: 10/20/2020 10:34:07 AM
INTERESTED IDEA, TELL NADER:
(stolded stold steeled from a Seeking Alpha Comment)
Here's an interesting thought. What if CYDY asks the FDA for EUA based on current data? Well the FDA would have to realize that granting EUA would essentially end the trial since patients who are severe/critical would not want to go into a trial where they might receive placebo when they have access to Leronlimab via the EUA.
But if the UK actually gets up and running in all 5 sites and is recruiting soon then the FDA might consider EUA so that not only do we get access to the limited supply of Leronlimab here in the US first, but also knowing full well that the trial will get the necessary remaining patients to reach 293 through the UK, where Leronlimab won't be available by EUA.
It's called having you cake and eating it too. Hopefully that's what they announce today.
(stolded stold steeled from a Seeking Alpha Comment)
Here's an interesting thought. What if CYDY asks the FDA for EUA based on current data? Well the FDA would have to realize that granting EUA would essentially end the trial since patients who are severe/critical would not want to go into a trial where they might receive placebo when they have access to Leronlimab via the EUA.
But if the UK actually gets up and running in all 5 sites and is recruiting soon then the FDA might consider EUA so that not only do we get access to the limited supply of Leronlimab here in the US first, but also knowing full well that the trial will get the necessary remaining patients to reach 293 through the UK, where Leronlimab won't be available by EUA.
It's called having you cake and eating it too. Hopefully that's what they announce today.
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