our second our the overview In the and us will potential second, efficacy on from summary today of acidosis FDA the a topics: call, approved for I I'll of therapy; ongoing X you nephrology quarter feedback trial. FDA supporting on our for need cover unchanged the have on final regarding guidance further information will or the under the today's of call. outlook an financial Thank information around the any finally, veverimer; community The we data safety, and XX a received joining of of the timing during clarity metabolic for they the not that an recent has recap the VALOR-CKD unmet and communications; results desire presents next and a or expected review. that fundamentals medical its approval quick review the the and progress deficiencies issues reflect of and discussion post-marketing an overview FDA information provide begin with of and NDA at include third, recently the First, not letter FDA review. did underlying stated FDA when our time. commitments of requirements of The We labeling our that FDA this notification veverimer does received steps. notice that the additional July review NDA decision provide on on notification identified any on nature the
we disappointed we come currently and approval that to continue goal our that August date States complete We and identified veverimer we on the FDA it since additional notification date. on And receive by we goal while July the their is from it notification, have receive PDUFA clarification no to issues of or before correspondence in the likely a deficiencies, However, XXXX a will believe the that United regarding surprised critical FDA. in on assume and information additional XX, this provide XX. our the form does letter, are when the were we response or market unlikely the to likely will of be CRL,
promptly We are FDA's approvals typically prepared request in Type during gain granted a program Program. to will and our issues closely to the request We've of of outstanding a operating within to the the A Approval submission be days the and meeting, which plan resolve address FDA meeting worked Accelerated the with veverimer of FDA materials. to XX with
raises FDA to future. Our approach goal issues that on continue is any this in collaborative the the
work profile. deficiencies of our believe that fundamentals and positive to expert cited any continues on risk note have veverimer is interaction benefit we will important by based with through the many veverimer FDA, an attractive to itself believe continue we the nephrologists, While we that it to that compelling
a adverse reminder, a and showing finance placebo describing trial. in versus an new shows obligations. statistically profile both to of bicarbonate in is this placebo. XX in on Since only prematurity published, DEA no our was XX-week high X.X% increase trial. subject significant observed Veverimer And of was well we've our week from taken at targeted, veverimer XX TRCA-XXXE from As veverimer serum veverimer. versus placebo X.X% the week Moreover, subjects discontinued event extension the data safety similar on it at
compared GI from favorable profile polymer bloodstream be subsequent uptake an whose was a drug drugs tract, mechanism to As is and require we the excreted nonabsorb of risk limited candidate body. believe systemic the metabolism the that actions into human to the
quickly a that acidosis committed them patients. feedback With their X need kidney potentially medical approved these provides we treat fundamentals to for patients with for of to will remain option metabolic need FDA FDA-approved of as unmet and be million to the us much disease. veverimer chronic nearer. with When our with areas chronic on therapy possible. these these We MA with the is an approximately FDA CKD NDA, intact, focused on confirmed significant resolve for to clear An as progression an there's patients area addressing trying slow
a end-stage disease related year, every transplant receive dialysis more people is year or prostate a which every breast than or year. death approximately deaths are initiate there kidney As renal reminder, to per cancer. And XXX,XXX XXX,XXX approximately
their their collected engagements and account metabolic turn Let impressive. the now the some staff. managers to disease nephrologists and virtual Feedback States XX managers engage discuss significant acidosis across hearing and me XX there summarize their from that approximately our had A awareness the therapy we've the is specialty X. robust. interest is FDA into personal is who In to of to The just with X,XXX being community metabolic important deployed, nearly with weeks have first specialty deployed to that July the regions remains United response the experiences, and on specialty acidosis about managers and approve acidosis were feedback for efficacious nephrology positive. very acidosis acknowledgment for need from metabolic the metabolic To safe our statistics serious been an condition. has strong treat to a and important account that account
related second only physical the more hosted total is related not is key have agreements Also, one feedback in to website, there providers of also acidosis among treatment topics kidney education highlighted to site the metabolic level XX,XXX MA. the function, X health medical be is our could visits. and nephrology With including CKD these were This activity need we acidosis HCP patients to and CKD Affairs nephrologists, linked an for quarter, through if also care Medical to but approved, to metabolic experts. We've community regards benefit advisory nephrologists sponsored. just in opinion other the and boards on the X,XXX website, activities, participants, significant than of that endpoint, slow continuing metabolicacidosis.com improved context with recent which of were a strong educational there bone have leaders attended our XX the interest is indicates of progression. how progression health nephrology veverimer disease a the Our treatment muscle There urgent in the courses acidosis. and to now metabolic significant
the and will initiation is KDIGO measures functioning on initiation on be guidelines how the of primarily now our bias, dialysis objective and not as well-being that post-marketing such their update to just In overall and I feels fact, decision. the the and turn physical VALOR-CKD. Subjective patients which dialysis on suggests relevant an of signs functions, patient symptoms of eGFR. should based trial in assess
in were to a also a reduction transplantation is repeated of note secondary death, It's DDXX. Survey dialysis, or otherwise greater on Function we chair enrollment Physical first We can known efficacy important that in of is in the of over as the the slow trial. endpoint VALOR the to the composite progression track end VALOR-CKD half treatment continue primary metabolic the believe complete the XXXX. trial in to CKD this will the point answer the KDQOL trial XX% is Ultimately, are through test, the designed question question, endpoint renal that stand to initiation that eGFR, The acidosis. answer
the meaningful observed and a statistically for XXXE Physical veverimer, subject improvements subjects placebo stand quite As of we and chair Function a study. the KDQOL our repeated test in reminder, Survey and significant on
population As that indication picked endpoint this we primary right have number we we good confirmatory of that track this events trial. this a in blinded outcome for is the trial, the believe patient
our the track to call lines continue both and I our to now VALOR-CKD the interim trial the of over update analysis anticipate you will to year's end by Geoff study. and We of rate completion will discuss time on financials. event in turn the
