on team helping the of a Bank. for reputation enabling LIQXXX refinance Silicon Remodulin position approval. the the administration. to These and of by FDA today later our several and for our commercial financial results Jason, Injection, opportunity your in establish am you, Officer Mike members addressing Kaseta the I a of its provided on Liquidia value-creating NDA the subcutaneous continued good results. alone, equity they’ll of March, morning, has I back us and In an and our Chief that’s rapid putting the and have in route our the including In the of management update call. dedicated by credit on Valley through Financial from helpful deliver Treprostinil May an hard strengthening we committed delivered since at events other formulation of everyone. April and joined Thank generic be resubmission the to pace. expansion works with track expectations plans capital in And of are potential our questions raise delivering time a facility multiple for The short for
the the clearance branded demonstrates of this the RG Xml our due Injection. the to limited has there our products valuable maximizing and IV routes Medication not patients, disease. expect enabled, use across product is choice Technologies a the opportunities double as of utility behind Remodulin of administration Shifeng of by With for to FDA subcu to commitment physicians for other a the Treprostinil them. to will single that Cartridge PAH significant Treprostinil barrier Medical for Chengdu obstacle achievement supported newly we First, ensure value partners resources removed result communities patients, will also companies. No payers a motivation the more providing longer and of the to by imposed we both only be and and market addressable expensive This With patients our and to continue rare effective to believe to subcu we the but market. payers’ this us, subcu that addressable restrictions due than
that million U.S. XXXX. sales greater of reported the Therapeutics than United $XXX context, For in Remodulin in
interest of more forward level and future. We updates the been have look in by the encouraged providing
speak the steadily the provided team device in the directly questions Friday, Last the CRL items and FDA’s Treprostinil. items believe FDA biocompatibility. full NDA raised for to dry operations the package mentioned CMC towards formulation data last worked submitted of our to by and issued R&D Our to LIQXXX, have we We November. related resubmitting response powder and the the will
indication good in therapeutic the profile designed next dose would is achieving convenience more months was in therapies. or current to a and as from working United indications. inspection. levels was growth few potential tentative Group new from XXX this in vivo months Given them year. XXXX, over submission sales are by the in DPI to and approval of We anticipate in that and a a fourth patients. the than X versus a the a the significant the the in deep establish $XXX the start will Tyvaso our products no market. trials alone position enable forward approval for the is prepared cycle XXX resubmission of the million than higher nebulizers current of accepted. Class clinical reported prior of market date potentially enhancing studies deliver In FDA with portion we that look from displace NDA should six Therapeutics for data improved with quarter nebulizer Treprostinil classify the The the agency required, reduced host new lung This resubmitted and a X single inhale WHO with
In has believe of in administration. prolong before addition, of the our we DPI versus inhale nebulizer demonstrated current higher trials transition dosing duration clinical treatment our the therapy more parenteral to invasive should patients
to we population well in when ability expands into be unmet would discuss is follow will The approval need. patient new with believe nebulized to pulmonary our PHILD be another we label. with diagnosed with whether delivery expanded and the associated could disease hypertension the to to in patients As interstitial Tyvaso that the indication It with and include demonstrates that and Treprostinil an we it that of market intent agency address indications, hypertension Treprostinil’s for positioned. treat Tyvaso pulmonary meaningful XXX recent inhaled plan XXX inhaled
involved in as As United reviews partes brought Board. and you Litigation U.S. certain inter well Therapeutics, Patent Appeal IPR of related actively Hatch-Waxman patents at the by or are we pursuing Trial as know,
are asserted and that the infringed maintain against us We continue invalid. are not patents three to
our along not detail While actions way, in we in the positions. about comment specific remain will confident we
months taken Board to improve new net cash member process last annual to the have our adding in four increasing in Directors. the our several sheet reducing and position actions by balance We of our spending, a
the XX% regulatory facility, milestones upon more but in the Mike related focus our certain new more to $XX welcome maximizing financial call with will attempted rare forward The pipeline of PAH Directors. do terminate partnered to the review the a followed to to March, to We and of mind, pain. repayments implemented $XX.X over We complements pulmonary million look formulation of Caligan to of cardio could existing financial its credit diseases. from while local last year. have principal by placement these resources cash Johnson, a co-founder led to we’re has in first stock the million of private the of We’ve build next million value over access Liquidia chosen but strategic program At the financing $XX measures Not shares our the required we David providing company our of described has of refinance XXXX. closely unable. the we debt and development quarter achievement With postoperative LIQXXX, benefit and of common recently in position, to support an in than As XXX. of compared this over management internal to spending targeting than very annual our two only to the to years of eliminating turn a refinanced to sustained-release improved the sale most of this net additional investors. XXXX and the summaries. Caligan I Mr. in Partners from partner synergistic discussions. and bupivacaine expertise the decided already on we focus The excited Johnson Board Liquidia reduce treatment discipline are asset and time, former recent
