$BIIB CEO Michel Vounatsos on current status of aducanumab filing: "We are actively engaging with the FDA as well as regulators in Europe and Japan, and we look forward to completing a regulatory filing in the US as soon as possible."
The re-dosing study will be single arm, so main focus will be safety and tolerability. Sandrock likened it to an open-label extension — but also said they will look at efficacy as best as they can on biomarkers like amyloid.
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Sandrock says Biogen built its Alz. pipeline with combination therapies in mind. He says the most obvious Alzheimer's combination to try is adding an anti-tau to aducanumab
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