SAF, I believe that the FDA would only be force
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Posted On: 09/17/2020 12:17:04 PM
SAF,
I believe that the FDA would only be forced to grant EUA if statistically significant reduction in mortality (the whole point of an interim analysis).
It would be difficult to argue against an EUA if the results are statistically significant in any of the secondary endpoints.
Remember, remdesivir was granted EUA under an adaptive trial with a primary endpoint chosen once it became clear that significant clinical improvement (rather than time to improvement), was not going to happen. The remdesivir trial had numerous clinically important secondary endpoints, that to the best of my knowledge, were not achieved despite 1063 patients.
If leronlimab meets any of their primary or secondary endpoints at interim, there will be quite a s-storm if EUA is denied. Approval may still require full trial and primary endpoint, with EUA P4 if secondary endpoints met but not primary.
I believe that the FDA would only be forced to grant EUA if statistically significant reduction in mortality (the whole point of an interim analysis).
It would be difficult to argue against an EUA if the results are statistically significant in any of the secondary endpoints.
Remember, remdesivir was granted EUA under an adaptive trial with a primary endpoint chosen once it became clear that significant clinical improvement (rather than time to improvement), was not going to happen. The remdesivir trial had numerous clinically important secondary endpoints, that to the best of my knowledge, were not achieved despite 1063 patients.
If leronlimab meets any of their primary or secondary endpoints at interim, there will be quite a s-storm if EUA is denied. Approval may still require full trial and primary endpoint, with EUA P4 if secondary endpoints met but not primary.
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