PS: Did anyone at Biogen ask the FDA to pull an aducanumab conscientious objector off their expert panel? ‘No comment’
Yesterday I reported that Biogen had dodged a bullet when the FDA recused longtime Alzheimer’s researcher David Knopman from this week’s expert panel review of aducanumab.
As Knopman made clear in comments filed at the FDA and in a separate paper he co-authored that appeared recently, he’s flat opposed to an OK at this point. He insisted that Biogen’s data don’t meet the FDA’s standards for an approval, relying on hopelessly biased post hoc data sorties, and that the big biotech can easily run a timely follow-up trial to prove or disprove the drug’s ability to help patients.
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