@davideyoungmd@adamfeuerstein@matthewherper Yes, but control arm was sub-standard. SoC in 65+ is Fluzone HD, not Fluzone. FDA correctly pointing out that standard dose control limits interpretability.
@AppleHelix Also note that $CAPR conveniently left out baseline PUL2 from their presentation. This is a pretty glaring omission, which I can't imagine they would've made unless there was indeed a meaningful baseline imbalance.
@AppleHelix A lot of reasons, at first blush. But one that stands out is that it's impossible to reconcile reported PUL2 numbers (4% vs 8% decline and 1.2pt delta) w/o a substantial baseline delta that predisposes control to faster progression. $CAPR
@A_May_MD@BayAreaBiotechI @CrocsAnalyst Yeah. Probably inflated EASI improvements across the board, which inflated cutoff based response rates. One of MANY reasons I wouldnβt draw comparisons to Dupi or upadicitinib yet. Not saying itβs inert, but itβs probably garbage.
Priority review and no adcom for an n=38, single arm, single center, open label trial w/ subjective endpoint in a disease w/ (allegedly) 27k US patients. Ok cool FDA $PGEN
@varma_ashwin97@Jn66039675@BertrandBio Maybe just low/declining NKG2A expression on a sub-population of NK cells make HLA-E K/I pointless? Who knows. I'm just spitballing.
@varma_ashwin97@Jn66039675@BertrandBio All I can say is that this/similar approaches have been tried by at least 3 different public companies ( $IPSC, $DTIL, $SANA) with CAR-T/CAR-NK, and it's never resulted in persistence even close to that of autologous cell tx.