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DewDiligence

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DewDiligence

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Re: DewDiligence post# 629

Saturday, 04/03/2021 12:50:54 PM

Saturday, April 03, 2021 12:50:54 PM

Post# of 754
ABBV—Rinvoq sBLA for atopic dermatitis extended three months for FDA to review additional data submitted during the review—new PDUFA is “late 3Q21”:

https://finance.yahoo.com/news/abbvie-announces-extension-review-supplemental-211800386.html

This is the second Rinvoq sBLA whose review was recently extended by the FDA—the other was the sBLA in psoriatic arthritis (#msg-162613514). In both cases, the FDA seems unsure about the risk/benefit tradeoff.

Bottom line: ABBV’s peak sales projection for Rinvoq may be too optimistic. ABBV has been saying that Rinvoq and Skyrizi combined will do $15B of annual sales by 2025.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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