. @BrianSkorney on Biogen & FDA: “Approving aducanumab, in the face of such an overwhelmingly negative vote and commentary, is virtually impossible and would destroy the agency's reputation at a very tenuous time for the regulator, ahead of potential actions on COVID vaccines.“
Raymond James' Steve Seedhouse: "Honestly, the panel was a disaster for aducanumab. And it is completely justified. There is no serious scientific argument in favor of anything other than a new prospective study of aducanumab..." $BIIB
Jefferies' Michael Yee thinks negative panel vote doesn't overpower FDA's desire to approve Biogen's Alzheimer's drug: "Tough Vote, but FDA Still Defended; We Still Think Can Get Approval"
Jefferies health-care strategist Jared Holz: "Our sense is it will be very difficult for the agency to take the results from today’s panel meeting and decide to approve Adu on its PDUFA date several months from now. (1/2) $BIIB
Jefferies' Holz: "In fact, we think it would be the most unprecedented move in the history of FDA, despite panel documents that we and many others believed were complimentary of the program in totality – of course understanding the more than mixed clinical conclusions." (2/2)
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