have we good Ronit. of review, acceptance ensure at the everyone. Based to an And our to high FDA its on priority Thank incredibly Omidubicel Cell access of approval. you, patient morning, Omidubicel with BLA Gamida upon milestone potential exciting priority
address this for motivated we to patients ensure defined it's approval, worked are have place, potential bring strategy Upon integral BLA has for commercial launch Starting are we unmet launch clear facility a as ready to potential to a to important therapy we need define quickly to are our manufacturing as we team With FDA now We diligently facility. was move our at plan. outstanding also address execution. focused readiness. a completion Omidubicel Therefore, the launch our that readiness following and on Gamida for with and patients. approval. in to now Cell of manufacturing, that prepared possible could leadership preparing great are the and This have launch to the well need Omidubicel unmet
ready are Omidubicel manufacture to We FDA approval. upon
Israel Our facility is in modular.
course and experience. will we has chain team a additional end add could standpoint. the chain the ensure to demand commercial our approach processes we launch finalized our have for both confident as for transplant So and We're facility production and increases center our from patient end demand a assure Omidubicel. identity requirements to support a chain from of to our positive validate process custody to supply The to ability of
to broad able clinical the manufacturing We have been manufacturing that we days. successfully Behind back Omidubicel deliver upon approval working FDA and have facility also also to in manufacturing could to Alameda have to transplant ensure XX centers hard Omidubicel. access within been that batches are patients
therapy. cell above that on the allogeneic two these and be XX potentially best as transplant upon undergo focus Omidubicel their X,XXX who patients to that approval, donor opportunities sources address potentially to this for first stem compared approximately cure. may outcomes year, of For a potential each There for we also patients improving an based chance age access malignancies, hematologic procedure may other or with FDA increasing on are key transplant feedback, the
we within insights, sources. data, find to are up and approximately compared and three is eligible that the that transplant number are cannot month the Omidubicel unrelated from For additional market the or who clinical research clear two potentially strength for may their predefined potentially based patient. to important deemed of experiences XXXX approximately Omidubicel average appropriate stem one but Unfortunately, align the consistent to to XX take allogeneic who to points outcomes year each donor to on provide This donor. our opportunities provide to a as malignancies, ages cell on there an months to patients and are transplant with of improve an hematologic with donors ability see opportunity donor improving the patients ability outcomes have other and extensive with cells, due
patients of access stem terms to the in regards disparity ratio their in increasing unfortunately these cell In allogeneic age for to access U.S. transplant. potentially
do you a non-Caucasian and of a low family to in finding match member you If access not are database. have public likelihood have the very a donor,
For that of chance XX% finding black patient a database. indicate than U.S. has example, the less in data in public a a the match published
less donor, As study will XX% our unfortunately match a to demonstrated our in they patients and for find stringent an cancer. the in III non-Caucasian. and racially Omidubicel patient to patients were Phase their we succumb ability our appropriate of matching patients cannot diverse ethnically moreover, study criteria as has
these to that of Omidubicel result reach combined the two peak market market anticipate we XX% may in addressable XX% mentioned, Julian approximately we approved, capturing share. once As if opportunities
equate centers in both and treated each with educating to centers to U.S. So XXXX U.S. with if in will reaching year the the understand payers We approximately XXXX this importance approved, to patients transplant the regards Omidubicel. of transplant the
optimized stem centers an as concentrated. and transplants perform are allogeneic cell have transplant the approach We targeted extremely that
approximately XX there transplants. centers those the the approximately in perform centers XXX XX% stem transplants. reference of U.S. are conduct allogeneic transplant For that cell of
medical actively affairs our the market we positive colleagues on supports engaged the our with have feedback Our data been blinded in heard centers, transplant clinical feedback and insights. have
payers. to Turning
groups with Our progressing. conversations these are
has payers team and regional been the level. actively payer national at Our with engaged
XX% reaching to of the out in who proactively be will We least allies US. payers cover at
data data, have We the Omidubicel on transplant. continue with majority the the overall health the to the value associated to-date. charges hear of published of and consistent proposition clinical represents including economic feedback strength we Hospitalization of
important in our reduction proposition. of terms and value utilization, of So healthcare in the the the days in hospital reduced days in resource reduced components ICU are Omidubicel very
saw we and for of reduction addition, healthcare In meaningful in These and transplant the number most the the payer, are center resources very visits. transfusion patient. importantly consultants a in reductions
potential hear continue and to stakeholders encouraged all are extremely of Omidubicel. excited are driven to We feedback positive by the and across
be XX,XXX are which blood with will the patients with population patients. the program over cancers the the U.S. population GDA-XXX equally EU, of Lymphoma largest lymphoma. encouraged in with financial approach is are lymphoma turn over in a approximately I/II effective trial. Phase clinical an Shai GDA-XXX continued our of to for now look to forward GDA-XXX unmet patients. therapies and for I We studied safe need is the the review with these new results. to advancement call the curative XXX,XXX and patient global of There the all of that refractory incidence We advancement the our is trial. will in a patient relapsed There