The U.S. Food and Drug Administration declined to approve donanemab's application because Lilly had not submitted data from enough patients who were treated for at least a year, the drugmaker"This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023.shares rose 1.5% to $284.5 in morning trade on Friday.
"Lilly's inability to launch donanemab near-term will prevent them from expediting their launch post-full approval by depriving them of the ability to begin to educate physicians and patients," said Citi analyst Andrew Baum.
Thanks. I saw this a little while ago as big drama for some within biotech vertical geeks like me. I started laughing because it’s about an Eli Lilly US FDA submission & the logo is Biogen. I’m still skeptical about this “disease” as defined area as well as some safety signals.
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