Aducanumab Approval

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    It is looking more and more likely that Aducanumab will get approved. Here is a link is to a recent and very interesting webcast that Biogen gave to the ADI. Aducanumab data review and Q&A with Alzheimer's Disease International | Biogen . For me the real gem is in the Q&A where Ms Budd Haeberlein discuses the imaging for the trial. During that segment she discusses how much imaging is appropriate for monitoring treatment with Aducanumab. Crucially she goes on to say, this is an ongoing discussion with the regulator. So it would seem that they are in label discussions with the FDA. In my view, this type of label discussion is one you only have after an in-principal decision has been made to approve.
 
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