like on #X brief the quarter. second to for you A key pleasure a Olivia, lot, have start summary quarter to and Slide I'd earnings on.
And highlights a welcome, call. just of the our Thanks everybody, with all real to
well review in in going in the U.K. as also the the can processes Europe, as process U.S. you various of As most obe-cel now and both for recently in the imagine, through we're
primary the an operational focus been that's So from perspective.
CARLYSLE have that with the and this target PDUFA year, the with and evaluated in remember, progress, that's date, addition, we're And pediatric of in that with we're obviously I advanced-stage on may second timeline.
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study update that's from X made we authorities. regulatory the through did data FELIX as we we've underpinning obviously, course quarter, that the the the very of importantly, More with clinical the study, pivotal much the on our the went of focus, filings Phase various
that do that program. quite longer-term Importantly, outcome. follow-up in to seeing study.
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look of terms inclusion, where had we of inotuzumab. in burden did as think, persistence therapies very high here with at very particularly and of bridging bridging a longer-term see inotuzumab and a outcome role impact I closer approach at time the the also in effective also, have tumor the that well into of patients of We use as
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that to manufacturing process that of we're and company growth have maturation and commercialization. work capabilities, their now group keep through the recognition and leaders remarkable -- obviously, organization through operations a their also the pushing fantastic Gray, getting have Claudia a role from manufacturing really as well. in and Gruell within access been operations filings a vice then and looking as market quality; a and on preparing in that; job first Stevenage; the technical regulatory of did into commercial and And for on the organization. amount Markus side, This done leadership promoted in and actually there the up head and to fantastic addition, we've through risen of has are who's than regulatory Braun that Dilip senior challenge, Chris obviously, Now, Andrea our been for with a Patel, on of presidents Mercedes of broader the talented driving is includes very side; setting side within the site job
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about part So holidays, reasonable date as date, target the first think that the when will is November XXXX, on you target timelines. assume in as operating if is the and happening a of early those and that, for to year-end you it middle be well of PDUFA about dosed patient think we're
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on what next to family for obe-cel we slide forward ALL switch sort continue on also, and initiate about And the that is additional long on that that, talk pediatric AUTOX. for well. update sort seen franchise pediatric but a as UCLH well of we actually going with not work as extend GOSH, program the obviously with when forward continue side work we also Slide Also our in AUTOX, program only briefly of studies with actually go do obe-cel. as I'd partners continue with time.
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that the just of environment the which have watched QX, presented on this that, autoimmune course space had dataset during with a the the happened conference. major Interesting So is quick many conference on carefully. side We the of in that word very EULAR conference. you of one
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When ALL interesting the programs of programs are and on clinical have pediatric directly, are the the give of T extent is the are [indiscernible] to appear but similarity to achieve the T we've what that currently of also you efficacy, differentiation obviously using Erlangen, understanding that various extent we're of in we attractive programs. a you, studies that those the starting program we but But very Erlangen, to terms good that [ those you to is terms in a set a has the the key of program -- very but obviously, we certainly right,
CARLYSLE SLE. XX, Slide on our X Phase study the study Now the study, in
first in obviously, a QX cell As dosed level patients XX study. We're during that continuing the I know be highly where, to QX, million enroll pediatric the at burden a is complete cells us using into a and we're highly is -- adult population setting. in ALL start-up the giving patients as we're in the X active level, and little those with molecular responses, happened in which also of to patient remissions planning QX, a we XX also in tumor indicated, study and active as reminder, that dose latter in part as in million the that level patient to obviously induce complete high
starting we're think We're at have perspective, I on in a get and with to that of stage. very data first to continue insights clinical a to collect year. overall, data a plan obviously an sort from additional we'll update So interesting late data the
pipeline Slide on other Now, XX. programs
working other there's of a on. you we're programs remember, number As
program additional indicated regards think we're already AUTOX, to into expanding I the with looking I indications. that potentially at
that's that's the quarter the in and we're in we by as we is program AUTOXNG. while has part is well of that patient during as to the patients, then, also something progress early quarter. the making quick just were first year that treated actually about the second the actually update as year, enrolling of obviously been sort That certainly a haven't trajectory going highlight So because on talked end next of be ongoing, on.
And and we'll
during second and So clinical additional the hand half of conducting.
With out come the to Rob, like you we our financial who to overall, year the that publications results. lead expect to programs over will also to through progressing we've been I'd related that, well,
