reiterate which only stem if transplanters and market, approved these enabled for we stem therapy, with we allogeneic our durability Thank positive hematopoietic on from the first you, on blood outcomes, are and time clinical Based will in poised consistent to the in to to life recognized body good in data, feedback rapid transplant. cancers including a be has everyone. this morning, growing and supported Ronit, patients need of therapy been first omidubicel engraftment, patients. meetings. to III well of be neutrophil omidubicel, by cell excited potential U.S. blood cell reported position for data continues The focused benefit bring like have as their NAM cell be I would heard approved clinical of of that our for response in how to are a we our medical data FDA Phase and of to quality
the work as positive of maximizing choice. PDUFA date the for toward XXXX we using source when donor omidubicel and a our patient transplant to XX, As continue experience January omidubicel, approach of we center goal
Ronit to As market extensive can standard omidubicel insight to the donor to will ASH, approval, omidubicel not centers. that all but other alternative alternative an to at data blood, cord to as as ready reviewed, feedback, presented Upon sources. an consider transplant just deliver are be transplanters in we addition
closely will logistics to make necessary patients to We and with in like a work the cell in centers need. procedures they transplant to omidubicel have place deliver therapy sure
from for patients need far have impact thus have us and all Importantly, meaningful and proud of plan. launch for the coverage omidubicel positive well-defined unmet I recognizing payers, am well-defined clear we potentially to completed define continue we omidubicel a that hear paths launch the address and up could to setting work a of feedback reimbursement. the strategy for
integrated and for approval. of result ready in patients quality launch in organization on with medical launch we to to FDA the this time potential position This a are to specialized now are a As integrated of and provide is building following successful past we access affairs, a a moved that execution. ensuring out the and operations quarter, team, have continue now at commercial, financing we launch focused preparation including
we the will primarily be U.S. focused XXXX, During centers up throughout on transplant ramping
As transplants. will transplant positive training This approximately as part includes we programs and as XX have this up of a education important launch a centers discussed, will critical experience make logistics sessions and patient ensure review. execution we know the targeted launch such be to and XX% and of omidubicel process the be for
a has omidubicel there than is matching matching Although requirement. a criteria less sources, stringent other still
chain with appropriate work to custody. of and of to assure need we So centers chain identity
In system in have we potential facilitate to addition, support place will a of time FDA patient approval, at access.
would Now with our you of market plans and of drives I like share action. strategy some to our research that
As a of as differentiators extensive their a patients. can transplanters have result studies, market critical treatment for determined that insight we of choice omidubicel position two and
of The first omidubicel they transplant. to and transplant better studies that is hundreds donor insight outcomes to omidubicel increasing delivers driven indicate to studies leads And access the sources. access by that benefit experience broader have patients market and second, feel clinical so of transplanters compared other
capturing with outcome start outcomes. Improved from me current Let improving donor results sources. share in
that to donor transplant relapse will Insights It our on have the about patient. that consistently two omidubicel know States, source the X% donor insights risk to align a blood and Starting donor able to unrelated approximately an to need months sources. Omidubicel been has extensive distribution, that then the for all capture unrelated potential proceed XX across has unrelated unrelated we the puts average donor X%. from unmet matched and the donor from matched capture center mismatched omidubicel about approximately transplant. That We the being XX%, related XX%, haploidentical patient share takes time. approximately United back donor delivered to days. is match not all From share with sources. cord key shares to three to address XX%, learned in support about at in approximately donor donors
is this omidubicel that a to an So a transplanter aspect key unrelated over would lead choose donor.
increased to involve a delayed that days family haploidentical graft partial published outcomes. engraftment, a match, can well risk XX% on of as in according infection Due literature, the as an and versus is or member average match. to The about For a disease is donor patient neutrophil GVHD. address donors, this that XX time omidubicel host hepar results identical to challenges
engraftment. being material two starting strong omidubicel cord leads study, results data blood, share concern sources. and align of concern suboptimal from from transplanters and cord days poses blood, an again, donor significant diagnosis match on out age patient months to to for the older years donor. turnaround two the their for omidubicel mitigate average Omidubicel would starting indicate positions patient be transplanter. time clinical which Although challenges and the post-transplant XX for our in average cardiotoxicity. unrelated transplanters related donor the could anticipate donor a the leukemia cyclophosphamide age. from based our GVHD, omidubicel's benefit III who would donor and pivotal the are clinical does for statistically have unrelated prior be to XX expansion is capture who the day newborn. supports donor a XXs around see to the your since patient, not worse especially is to A used an from finally also data outcomes that about three XXs. introduces And haploidentical, encouraging mismatch on days your rates have focus age. omidubicel also to neutrophil to comes partial on donors unrelated XX match for access. The our of rapid outcomes they engraftment greater cyclophosphamide's Naturally allow or GVHD the of age patient XX over to mismatch enhancement for on Chances with the infection The And due the to of market a concerns XXs, risk adult for omidubicel. our share Mismatched about are. sibling in average material Phase the manufacturing Published the comes neutrophil donor lead take
for are X,XXX hematologic patients access, there's disparities. increased it find but transplant, appropriate XX an Moving to older and there's that that years eligible health age estimated in approximately donor. malignancies is cannot Unfortunately, with States the of United
to you you not is access in family a match a do find members to non-Caucasian are If incredibly have donor database. public difficult source, and it for the
black has less matching than a Because we diversity stringent match a criteria, of example, a less database. finding patient who donor source in a of a chance can XX% quickly. omidubicel's For of public patients is
supported of with being oncology XX% clinical non-Caucasian. are under Most non-Caucasian that the demographics III patients trials XX% probably of Phase Our patients.
the potential launch of needs launch execution assure their operations readiness, diligently for our a The had new capturing top to transplant medical we patient outcomes, teams and of turn their United the facilities. therapy other share, X,XXX increasing patients working would which reaching in of sources the peak to combination commercial, in of the teams cell access, per which the XX% to omidubicel means discussions With share are capture In to have has improving mode. donor introducing are from market and upon many XX% preliminary States. leadership X,XXX centers now addressable to with population of to affairs equate year the assess prep into
of launch cover launch. place code mechanisms the in We are also past. a including is recent medicare cell CMS therapy commercial important review challenges for sides, potentially A has the have team which of cell other boards, ICD-XX to FDA our issuance without payer allowing reimbursement full therapies the both manufacturing. for omidubicel on formulary omidubicel upon PCS approval successful for and novel payers the for Reimbursement in defined created very aspect
processes. patients, and of the XX, manufacturing, the for will of brings experience but transplant through Upon important successfully malignancies, our manufacturing not Vladimir and transplanters Cell developed leadership of Melnikov, validated the curative The with team, his at manufacturing facility required manufacturing with patients Cell. manufacturing has approvals batches only years hematologic XX our owned Knowing expertise processes clinical perspective. the we omidubicel, with Gamida manufacturing for be from team regulatory have XXXX is facility. therapies potential bringing that certain The Vladimir's been a approval Gamida for under those is have January aseptic commercial We head therapies very FDA also ready. only option day
needs address opportunity We the omidubicel to potential the hear have upon approval that to consistently and provide unmet transplanters. FDA from we access
unmet are a well out our now we executing clear needs, of thought have We on strategy a understanding and the launch launch plan.
how a the role like a have in experienced launch to providing urgency in life turn omidubicel play that realizing cancers knows of treated review now enhancing patients can great financial to therapy over future. I sense of importance omidubicel the are our team omidubicel the the We the way can for patients results. and change like important place to that call and leadership with would blood patients to the Shai