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Posted On: 12/25/2020 2:32:18 AM
Post# of 148902
"Leronlimab would not get that unless the FDA has high confidence in the drug."
--That's what I was thinking. FDA must know something about the data??
"
Best would have been full approval lol)"
--Seems like a precursor to that, ya think?
"The trial site hospitals may decide that LL for all severe/critical is a potential way to clear out their ICUs.
--That's a great consequence I didn't think of.
Incredible timing, to say the least. Christmas Eve.
And, what a grand Christmas present to families of people in critical condition.
"The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12." - isn't that close to de facto approval?
I hope they allow this in entire hospital systems to which the trial hospitals belong, or dramatically increase the size of their ICUs at the trial hospitals - anyone in critical condition.
Since "long hauler" can happen to m2m or s2c, I think LL should be given to both.
Q: If they're going with open label extension, why not get the placebo patients started on it? Same diff' yea?
Can people on placebo file for eIND?
********************************************
Thanks for everything, gentlemen - MERRY CHRISTMAS TO YOU AND YOURS.
--That's what I was thinking. FDA must know something about the data??
"
Best would have been full approval lol)" --Seems like a precursor to that, ya think?
"The trial site hospitals may decide that LL for all severe/critical is a potential way to clear out their ICUs.
--That's a great consequence I didn't think of.
Incredible timing, to say the least. Christmas Eve.
And, what a grand Christmas present to families of people in critical condition.
"The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12." - isn't that close to de facto approval?
I hope they allow this in entire hospital systems to which the trial hospitals belong, or dramatically increase the size of their ICUs at the trial hospitals - anyone in critical condition.
Since "long hauler" can happen to m2m or s2c, I think LL should be given to both.
Q: If they're going with open label extension, why not get the placebo patients started on it? Same diff' yea?
Can people on placebo file for eIND?
********************************************
Thanks for everything, gentlemen - MERRY CHRISTMAS TO YOU AND YOURS.
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