Chucke, it would be beneficial to do some reading about ARIA and ARIA-E. Instead of "brain bleeding" the medical term is ARIA or amyloid-related imaging abnormality. In other words, it is a medical adverse side effect of the brain seen on imaging, such as inflammation or edema (swelling) and can have many variations including no physical effects at all. It is not a brain hemorrhage, which can have many causes. There's a lot of literature out there today about aducanumab and other monoclonal antibodies which have gone before it. From what I have read today, aducanumab has had no deaths but has had some patient drop-outs due to ARIA. The two large Phase III's at many sites are closely monitored for ASE's related to dosages. I wouldn't expect this Fast Track to be extremely fast due to the length of time needed due to the large number of patients in the two Phase III's (I believe a total of 2,700) at many global sites.
As a former shareholder of Elan which was one of the pioneers to use monoclonal antibodies (bapineuzumab) along with several well-known partners, I remember something about the disappointment when bapineuzumab was determined to be unsuccessful. I had sold out as the signs were beginning to become obvious. Elan is no more but what others are now learning as so many AD trials failed is more than valuable.
Just one more thing: PBT2 should not be compared with aducanumab. The only thing that they have in common is that both target amyloid-beta.
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