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Posted On: 12/05/2022 10:41:35 PM
Post# of 148878
Re: chazzledazzle #130945
the reason I asked that question is because, the fda will be receiving all that data when they go to assess leronlimab for safety. will the fda also go on to assess leronlimab for effectiveness with that data? they surely can if they wanted to because they would have the data. but will they. I don't think they will.
yes of course, I know that the peer reviewed article will show that leronlimab was effective, but i was wondering if the fda will come out and say that leronlimab was both safe and effective when they lift the hold.
and does this have to come from the fda for sidley austin to proceed in their suit for damages or can it come from the peer reviewed article?
what was the purpose of the investigational brochure submittal outside of providing documents? was there a deadline by which the right to submit for damages would expire by?
yes of course, I know that the peer reviewed article will show that leronlimab was effective, but i was wondering if the fda will come out and say that leronlimab was both safe and effective when they lift the hold.
and does this have to come from the fda for sidley austin to proceed in their suit for damages or can it come from the peer reviewed article?
what was the purpose of the investigational brochure submittal outside of providing documents? was there a deadline by which the right to submit for damages would expire by?
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