I'd be really interested to know what@otherperspective and other posters more knowledgeable than I think about whether this Aducanumab approval changes the approval prospects for our treatments. I wonder if the SP appreciation today is as a result of this with investors thinking this signals a new approach from the FDA.
- Does it suggest a shift in approach from the FDA or should it be viewed in isolation?
- Did its phase III trial miss primary end point? And was it approved on secondary endpoints?
- What about the black letter law approach to MOA in the FDA hearing re Ryoncil? Is that out the window too, or are we reading too much into a single decision by a big cumbersome and capricious agency?
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