Thanks, Dan. and everyone, afternoon, joining thank for Good you us.
completed preapproval expected we very finished FDA commercialization. am As for action an date pleased happy the with the is tomorrow's preparations our I be DefenCath, FDA, pleased company site EIR a progress target toward as Establishment made inspection for from well are And Report we that very as that pursuing or final the for the dosage approval CDMO Inspection imminently. announce NDA approach in issued to with to has I'm September, outcome.
and all CorMedix thank status around for congratulate clarity CDMO, Pharma Rovi in our who our will process. NDA well inspection, preapproval of and thank the Services the to worked review employees, the commitment with as diligently additional DefenCath. external inspections as like I'd CDMO CorMedix their Industrial for to provide of Phebe the have preparation consultants and and
deficiencies, of are communicated present action aware earlier lead could host And items any SEC time, tomorrow. day call last conduct call the to is day take our for CorMedix this today, potentially that and at we FDA negative could we has was under Certainly, our or than working ahead target date, company it's taking outcome. us frustrating they were of this action this but PDUFA not a to would requirements, action application towards hopeful on the that outstanding to FDA a that review date. our
with regard, hires preparations commercial market pricing our of that launch our in field pharmacovigilance. key number In safety operations, advance of training, a in and target have access, we sales date, new and and drug commercial for action contracting, medical intensified
of scale. are as a capabilities require for on We that building significant well relying activities number as in-house, vendors certain larger external
specific do a Our likely first as over FDA the inpatient before as coming approval field external team focused key account expert of relationships final access institutions the managers, of advisers a targeting health the in-house event deep systems. segment and well launch In will only. end we on receive XXXX, at initially combination quarter are consist high-value of of commercial target the with days, the inpatient market we
commercial assumptions factors, around sales Center ramp CMS, Medicaid external and of from be may impacted Services, launch the notably timing reimbursement for reimbursement Our for DefenCath. outpatient and or most by the Medicare around guidance
in that properly CMS, active case discussion product an our X drug with Part DefenCath Medicare as the outpatient we engaged been B. should the Over back-and-forth making an months, under past be reimbursed have
significant provided the separate rationale and in obtaining government with health support payment. legal, economic We commercial have of DefenCath
transitional separate Medicare Part TDAPA. B a drug add-on payment under would is DefenCath to be dialysis ineligible renal determination service, that alternative payment for a The CMS a or
the standpoint, and our financial on Medicare strongly current Part modeling service dialysis the to to base the maintain feels of not consider does analysts should investors as and our B. reimbursed therefore, properly case renal separately we from our fall While DefenCath that statutory company within a definition be TDAPA, guidance
CorMedix feedback Absent from as submit service. prior an do the not application we Part from CMS is at for renal that XXXX, on CorMedix TDAPA also is FDA not an direct is preparing J for intend to submit application approval. this to X. the does advising and submit to The a application CMS January January deadline, TDAPA submit company that to NDA, on January product dialysis CMS believe X, provided deadline for to to see an code our for reimbursement, an application B product time, unique
application a to quarter with deem At service. a CMS implement, process fend quarterly to be full to a TDAPs renal dialysis should
the may could of reimbursement that launched is any TDAP around prolonged impact Our a timing will, submission impact from application. determination guidance a J government any noting such product adversely It shutdown timing TDAP review the application the and worth or also code quarter. CMS either therefore, outpatient and of lag by of a
With respect final DefenCath launch FDA P&T of the inpatient systems, the in quarter health begin formulary XXXX, approval. first soft be seeking to approval only a contemplate at this a process NDA has we potential would can launch for we as various the once of
with months, key opinion systems. identifying have of and health relationships with past Over systems, targeted those the engaging several key process target we accelerated have advisers leaders that external the relationships building existing
on months X The P&T to process get anywhere the from X System. Health varies looking to depending
We land some to able formulary hopeful be quick positions. early are to
At more outpatient the to However, toward slow the regulatory launch the a earnings X now for around lag timely implement I of FDA meaningful year-end launch. inpatient the contributions ramp progress during on call discuss NDA X XXXX. of months turn not would launch Provided we approval, we will call. to granularity our update and expected revenue inpatient timing reimbursement, half of ramp over first to and potential we time, second anticipate over approval. obtain Phoebe to until discussing Phoebe? the to expected formulary the be side any inpatient due outpatient expect present is timing the and the
