"The trials were terminated in March 2019 when a f
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Posted On: 06/07/2021 1:29:42 PM
"The trials were terminated in March 2019 when a futility analysis determined aducanumab was unlikely to outperform placebo at completion....In November 2020, an FDA advisory committee voted overwhelmingly against the data presented.."
"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," the agency added.
"..previously unavailable data showed the drug actually reduced.."
"..when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug's clinical benefit."
https://www.medpagetoday.com/neurology/alzhei...ews_Active
BIIB pps is $286 5 mins ago
"Official death certificates recorded 122,019 deaths from AD in 2018"USA.
"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," the agency added.
"..previously unavailable data showed the drug actually reduced.."
"..when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug's clinical benefit."
https://www.medpagetoday.com/neurology/alzhei...ews_Active
BIIB pps is $286 5 mins ago
"Official death certificates recorded 122,019 deaths from AD in 2018"USA.
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