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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