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Posted On: 01/23/2021 1:14:00 PM
Post# of 145873
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Re: reallypeople? #74002
On OLE , i feel most of the articals and studies that looked at trials that had OLEs don't have any frame of reference to a pandemic. They are right in that most come with drugs that have shown to have good or excellent safety profiles but comparing a drug going for a BLA to LL going for a EUA during a pandemic is two different things.
I think this is the FDA sort of sticking its neck out just a tiny bit, with a drug, with a excellent safety record. They can say if the trial data is good that they sort of made it available, and if it is bad that it was still an experimental treatment.
I think this is the FDA sort of sticking its neck out just a tiny bit, with a drug, with a excellent safety record. They can say if the trial data is good that they sort of made it available, and if it is bad that it was still an experimental treatment.
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