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Discussing Biogen's Regulatory Chances for Aducanumab in Alzheimer's with an Alzheimer's Expert.

Ticker(s): BIIB

Who's the expert?

Name: Dr Russell Swerdlow - MD

Institution: University of Kansas

  • Director of NIH-funded University of Kansas Alzheimer's Disease Center.
  • Currently manages 300 patients with Alzheimer's disease and very familiar with the Aducanumab public literature.
  • Research is focused on brain energy metabolism, the role brain energy metabolism plays in Alzheimer's Disease, and how to manipulate brain energy metabolism.

Interview Questions
Q1.

Questions to come from STAT Reporters!

Added By: joe_mccann
Q2.

Hi,
Is there any new information on when the FDA will finalize their decision on the aducanumab review ?

Added By: userccea4246
Q3.

Considering the new data provided by Biogen, which could be the arguments for the FDA to reject aducanumab ? How strong is this data ?

Added By: userccea4246
Q4.

Given the very limited availability of PET scanners around the world, how feasible will any anti-Amyloid treatment be for the general public?

Added By: usera9aa0bf4
Q5.

So if this data set is similar to others we've seen before in terms of issues with interpreting the data, why go ahead now with an application?  What is the difference in this case or in Biogen's estimation?

Added By: katy riddick
Q6.

Instead of building a new global infrastructure in years or decades, how much faster could patients be served if there were a new noninvasive test that doesn't require spinal tap or blood draw?

Added By: usera9aa0bf4
Q7.

How do you think patients will be diagnosed if aducanumab is approved? Not enough neurologists, cost of diagnosis and monitoring for ARIA will all affect the real-world experience

Added By: userb14365a2

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