- Feb 5, 2006
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From November:
So, it was rejected, amirite?
Nice try!
Today:
Seems like DOJ should be investigating whatever corruption is going on at the FDA.
FDA advisory panel not convinced of experimental Alzheimer's drug's effectiveness | CNN
An advisory committee to the US Food and Drug Administration largely concluded in a meeting on Friday that there is not enough evidence to support the effectiveness of the experimental Alzheimer's disease drug aducanumab -- and thus clinical data do not support approving the treatment.
www.cnn.com
An advisory committee to the US Food and Drug Administration largely concluded in a meeting on Friday that there is not enough evidence to support the effectiveness of the experimental Alzheimer's disease drug aducanumab -- and thus clinical data do not support approving the treatment.
...
In response to a question about whether it was reasonable to consider data from one positive study as the primary evidence of aducanumab's effectiveness for the treatment of Alzheimer's disease, none of the committee members voted yes -- 10 voted no and one was uncertain.
...
In response to one question about whether the positive study provides "strong evidence" that supports the effectiveness of aducanumab for the treatment of Alzheimer's disease, one committee member voted yes, eight voted no and two were uncertain.
...
And in response to a separate question about whether another smaller study provided supportive evidence of aducanumab's effectiveness, none of the committee members voted yes -- seven voted no and four were uncertain.
...
During the meeting, some of the committee members also raised concern that questions and data were presented to the panel in a way that was biased, "one-sided" or favorable to the drug.
...
In March 2019, Phase 3 clinical trials of aducanumab were discontinued because a futility analysis found the trials were unlikely to meet their primary goals at completion.
So, it was rejected, amirite?
Nice try!
Today:
In controversial decision, FDA approves first new Alzheimer's disease drug in nearly 20 years | CNN
The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's disease -- despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment.
www.cnn.com
But you already knew that.The US Food and Drug Administration on Monday approved the use of the experimental drug aducanumab for early phases of Alzheimer's disease -- despite an FDA advisory committee concluding last year that there is not enough evidence to support the effectiveness of the treatment.
Seems like DOJ should be investigating whatever corruption is going on at the FDA.