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Making sense of the about face for Aducanumab in Alzheimer's after Biogen reported full analysis of its Phase 3 trial suggests success at the higher dose.Ticker(s): BIIB, LLY
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.
Questions to come!Added By: joe_mccann
Does Biogen’s “high dose exposure” hypothesis make sense?
- Do you make anything of the different slopes of the high-exposure curves? It appears ENGAGE sub-group has most of the benefit between month 6 and 12, before they would receive 10 consecutive doses, vs. EMGERGE most benefit months 12 to 18.
- Do you find the ENGAGE subgroup analysis supportive of EMERGE?
What weighs heavier the positive EMERGE results or the negative ENGAGE result?
Do you want to see another study? If so pre or post approval?
Do you have a view on the statistics here? Any concerns about the ITT analysis which includes 40% of patients who were administratively stopped?
What do you make of the ENGAGE study clearly showing amyloid plaque reduction but no benefit on CDR-SB?
- Do you make any read-through to Biogen’s comments about FDA saying it would be “reasonable to file an application”?
- How do you expect the FDA to look at this data? What will be their key questions? What are the key updates or analyses we could get at CTAD or during the FDA review that would change the prospects of approval one way or the other?
- Do you have any experience with the FDA neurology group? How accommodative do you expect them to be?
- Do you expect an Adcom?
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