us. Good for morning, joining everyone, thanks and
countermeasure to completed You their the brincidofovir. one very are imagine, to filing the satisfy bring a culmination one national to excited is second NDAs, strategic effort This can X BARDA of mandate suspension of separate for have alongside and we Tablet stockpile of the for the for formulations years a smallpox. of to
work know, this challenges. you was not its without As
satisfies focus countermeasure emergence resistant not one. mechanism intentionally to this and to decision, addresses have granted. to lethal to It's for smallpox the data during simple. There's part easily and developed the though, resistance that therapy need have and have not out-licensed countermeasures, clear, strong X.X of SymBio. use of indication. which pediatric the NDA therapy ago, well critical lives suspension has through to potentially that of all brincidofovir an vaccines a was for as to outbreak. BARDA that. optionality that likewise dosing important mandate imperative of compelling And natural use It's milestone on is vulnerable second The alternative this element to other as formulation so that narrow for brincidofovir use of combination It a of a a the as with submission. in is crisis adults. of we here, administration our team during it's with saving is course compatible Brincidofovir joined took deliver is value indications important a released is I need, and the our It's brincidofovir years or delivers The alternative short for reason for to as a The available we need decided we that also of an strains So of need. an is brincidofovir it selection. maximizing a
data to focus dosing. generated off and animal resistance survival an attractive the to final this support we as our paid enhance have to human elements appropriate confirmed successfully decision Our evidence primary the We've support on endpoint. of provided work profile
path about their was And engagement relationship this key enhance of in out are in are with our the transparent just They We in leadership pleased partner continued with submission, this we to COVID very had recently, I the to a as conversation excited procurement. BARDA keen about work. midst BARDA also potential forward program. a very to and the reaching their
we approval. contract could prospects very be of execution with an of While a about of there next with communication is first antiviral and RFP The that positive PDUFA this it of the a the about of a news COVID a our no for from potential formal priority but can filing flow in year procurement of date. is acceptance course, very them. away on busy that that next came feeling a be issued we clear quarter BARDA, an remains smallpox second expect the is course, assurances, activities, the time program obtaining of conversation FDA's
the this to early expect priority from month will We hear December. decision obviously requested them review on late FDA's or our date. impact PDUFA
remain first our mentioned on visits DSTAT III restarted early of patient initiate next trial AML. or track acute leukemia recently, to in I myeloid we Phase for the As year. work We
this be enough chemotherapy. to XXX in diagnosed healthy AML are reminder, will a trial As that intensive receive newly adults with
early at that on an survival Recall that designed and event-free study the we've in efficacy survival. XX trial are endpoints patients. this analysis Importantly, primary overall
had American we're were let expand plan our our XX-patient encouraged ensure this Journal assessment. a have efficacy. link the we a secondary we MRD the a Association, in Medical of by disease MRD MRD indicator but with published key historical Allen detailed as on This and the between to outcomes an I'll meta-analysis FDA of is of or strong AML. this, data key and early choice which suggested to aligned as patients with recent minimal the a how of validates conversations well. in of on is status in We is own takeaway element endpoint interpretation data, residual our assess with Consistent
important investors meaningful will XX-patient efficacy an both MRD, Our a success predictor it III be making management and data of a strong providing potential Phase with catalyst. readout, and therefore, assessment of
comments our make let me few about Now COVID. in DSTAT trial a
in investigator other based partly momentum for challenging been enthusiasm. II a trial been our feedback, about sponsors, Allen one a a more let And has what let of a has to this investigator Phase seeing we this level. me very quickly. would anticipated, describe I'll felt on it enrolled predict. little we We early As about high detail but fact, portion study couple have at and very observations the here, of we're make good
tools patient how situation. most this heterogeneity manifests tailored patients, disease First, we such will it in therapeutic a a continue require significant to There's need to multiple believe there's in here. likely
For therapies to directed more the also that a therapeutic to target. better like single likely narrow DSTAT reason, are achieve a multi-targeted that may it's highly outcomes compared same specific
provide Second, the I've drug for seen. as benefit rationale is any as this compelling to
Third, enthusiasm support believe this able the being data strong. physician DSTAT to fourth, participate of some remains share in decision the patients future disease to on will we And in trial.
we through. plan we as it and a low result, unblind is value. So sacrifice would data to but significantly expanding were from trial we trial, That We a would each by the switching population of the cohort. accelerate this see believe, as which scientific be said, we our or identified to rigor to data, to optimistic will we data, each not opportunity, single-arm as of expect design patient it available access
out that of to randomized guide activate reach be sites patient being to will and be going to the a both to of least Phase I'm our first the where a first trial. money. building days, We With will have II the few cohort, patients on which new patient next data. also forward. resources data population from and assess inform here, AML Data endpoint had that, resources time provide cohort in we the in ensure biomarker and strong the from help of we're just should we're at both would the first position let sites we're level me have Allen. put on with population. enrolling recently of each disciplined these and meantime, investment and over interest couple the able us least growing both the to in our not high overextend program, in turn right to of at a quarter. of unsolicited on a ensure the a We're this we speaking able the we away a couple We'll call In actions