Decision time for the FDA... Why would they req
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Posted On: 08/12/2020 6:29:44 PM
Decision time for the FDA...
Why would they request P3 versus EUA P4 approval?
"Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.
Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects"
https://www.fda.gov/patients/drug-development...l-research
Efficacy? The National Early Warning Score 2 (NEWS2): In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group ( 50% vs 20%; p=0.0223 ).
Safety? no question...
Competition for a limited resource? UK, European Union, Israel, Mexico...
Time is ticking.
Why would they request P3 versus EUA P4 approval?
"Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.
Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects"
https://www.fda.gov/patients/drug-development...l-research
Efficacy? The National Early Warning Score 2 (NEWS2): In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group ( 50% vs 20%; p=0.0223 ).
Safety? no question...
Competition for a limited resource? UK, European Union, Israel, Mexico...
Time is ticking.
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