Dr. Yo says inclusion criteria for eIND is very ch
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Posted On: 01/01/2021 10:59:59 AM
Dr. Yo says inclusion criteria for eIND is very challenging
A Twitter follower of Dr. Yo posted the announcement of FDA providing guidance for inclusion/exclusion criteria under eIND. If you want to see the tweets, use this link:
https://twitter.com/YoDoctorYo/status/1344880468488028160
In case you don't follow Dr. Yo, he is an anesthesiologist. If he gets Leronlimab for this patient and posts the result, I will post on IH.
Here is the main gist of the thread:
Dr. Yo
@YoDoctorYo
9h
Going through this right now for a personal case. The new FDA inclusion criteria for eINDS is VERY challenging. The PEEP and PF ratios are new hurdles. Stay tuned.
TL
@ThipL12
9h
I can see your point with PEEP <15cmH2O being a challenge hurdle! But the phase 3 results analysis will be due out in late January in a short time. If results demonstrated efficacy, the FDA has moral obligations to give an approval or at the very least EUA!
Dr. Yo
@YoDoctorYo
9h
I don't have that long to wait. Need this eIND for my friends mom. Everyone on board but the PF ratio is the hurdle. If tomorrow we are over 150, should have Leronlimab on the ground Saturday morning to her. But got to clear that hurdle!
TL
@ThipL12
8h
When they’re on >15cmH2O of PEEP, I doubt S/C C19 patients should have PaO2 of >150 unless you also gave them 100% FIO2. To meet the criteria could you possibly wean down the FIO2 follows by an ABG later? I wish your friend’s Mom full speedy recovery..
Dr. Yo
@YoDoctorYo
8h
It gets tricky when trying to manipulate the FiO2 considering how severe the ARDS and poor oxygenating she is. But I think I bought her some time with ivermectin so hoping that we are able to cross the PF>150 tomorrow and get the greenlight.
A Twitter follower of Dr. Yo posted the announcement of FDA providing guidance for inclusion/exclusion criteria under eIND. If you want to see the tweets, use this link:
https://twitter.com/YoDoctorYo/status/1344880468488028160
In case you don't follow Dr. Yo, he is an anesthesiologist. If he gets Leronlimab for this patient and posts the result, I will post on IH.
Here is the main gist of the thread:
Dr. Yo
@YoDoctorYo
9h
Going through this right now for a personal case. The new FDA inclusion criteria for eINDS is VERY challenging. The PEEP and PF ratios are new hurdles. Stay tuned.
TL
@ThipL12
9h
I can see your point with PEEP <15cmH2O being a challenge hurdle! But the phase 3 results analysis will be due out in late January in a short time. If results demonstrated efficacy, the FDA has moral obligations to give an approval or at the very least EUA!
Dr. Yo
@YoDoctorYo
9h
I don't have that long to wait. Need this eIND for my friends mom. Everyone on board but the PF ratio is the hurdle. If tomorrow we are over 150, should have Leronlimab on the ground Saturday morning to her. But got to clear that hurdle!
TL
@ThipL12
8h
When they’re on >15cmH2O of PEEP, I doubt S/C C19 patients should have PaO2 of >150 unless you also gave them 100% FIO2. To meet the criteria could you possibly wean down the FIO2 follows by an ABG later? I wish your friend’s Mom full speedy recovery..
Dr. Yo
@YoDoctorYo
8h
It gets tricky when trying to manipulate the FiO2 considering how severe the ARDS and poor oxygenating she is. But I think I bought her some time with ivermectin so hoping that we are able to cross the PF>150 tomorrow and get the greenlight.
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