Dr. Martine A. Rothblatt
Thank you, James. morning everybody. Good
a press after over business Benkowitz and United I James came quarter with President with but XXXX. be everything overview release pleased today how our available Mike of of the on out. the Chief I'm We're in as results pleased Therapeutics brief metric will quarter very I and the every and past we're they're Operating and financial the our third to mentioned Officer, and pleased give joined James answer questions As he by
a Laureate was successfully would highly himself be we our but this as great hypertension form thanks a that steadfastly who less of of Orenitram those my an pulmonary at effective on are to some that our correct the unfortunately hypertension the for discovered of he Sir accomplishment pulmonary rate something kind really bit Therapeutics. month exciting pulmonary that perennial on he patients Remodulin. would going worked guy the be did that for developed deep a give not the to business Dr. Orenitram. just it the label by new was overview FDA hypertension. developed was And of or outright morbidity really on geeks of ingredient was with This he passed Nobel for into colleague was reduce the to brand spot And about hypertension in reported we drugs interesting be of mortality. him decade. treat of treatment that the me which is It's name And pharmaceutical active treatment able could a United Let he that that treprostinil for it's much you Last on a reduce signal history on progress oral even though John of progression Petersen Therapeutics. for an now used the API United approval treprostinil pulmonary Vane, believe or
with course always and not bit to me John month. with years the this be that this going our of just the like is up XX we was still on last and you get Sir of FREEDOM-EV study we that up we're of of a for then FDA fingers approval with right, thinking shared this beautifully as crossing a slug was away just XX excellent thinking able But occurred maybe results Sir maybe end during moment results a it's earlier which a kind final pill you when you're Laureate stamp to Nobel until John have little year executed work right, years everybody and that absolutely the and geez the pinch you
to but two So on in years think double really -- able that number really great the to XXXX. after that since years I we're was be two the then able that results Orenitram last actually three a beyond doubt of earnings I only results due the our that and to to the next following believe that FDA again personally Orenitram have approved that that. the not the going on over to patients beyond three signal double be of label the call we also to
So for it's new Orenitram thanks this our of for a to that good accomplishment outlook label expanded greatly product. really
fewer we flow that news perspective of in really Now than next had coming months. to we things have up new next months. expect the XX approval there's hope XX the greater FDA. next be we do three there the approvals months than good no and for Therapeutics United some for frankly a In are for other category XX the the never And Therapeutics during United in out
waiting Remodulin. for those for one that implantable final the ISR, a approvals been years hope about First system as know. us final Medtronic get have we XX its been before the commercially Actually could who just that we we're on launch and you while approval from that have it's We Therapeutics also United for for for to got of approvals the project. working FDA the following already
on whole SteadyMed. needed third next to or next And get to expect been acquired with very tissue disease. to also transformative would on hypertension of following all the our spectrum pulmonary then tissue the and we the months segment along acquisition Second patients have would the activate especially button such months. for from for we is large those it of And on kind a there's get a disease have kind that tiny of have RemUnity within launch transformative make in approval devices. we a patients who FDA subcutaneous very they Remodulin. the approvals we're regulatory the analogs you us and states all product a for did that an FDA That for on of that final This commercial be these population be actually initial RemUnity XXXk approval of an of we waiting that connective special and expect XXXk suffers of up segment XX that expect that to connective of as Trevyent one we disease approval of for we difficult for truly going scleroderma for of that just the XX conditions the Raynaud's the that's a
with the and RemUnity expand been of subcutaneous us plug think beyond that the or patients believe so product. simple, a that truly one well just is with involved significantly to anything able I reach that patients to going that play together that no allow number system, help to for the that the buttons dosage to I Remodulin we like So serve to of Trevyent the being patients adjust have and already have
and stealing ever more served the patients helping now we of won't at Speaking we but be of thunder the have treprostinil are for my company. we a number with than angry his of serving I in bit colleague serving, me that patients history hope little Mike are
of XX So point launching each number we've true are it's of because by at new not really serving new launch to have cusp of UT. XXXX the label we're expand ability can a of with for Orenitram here to really products significantly more months which a in than that it's before be the served products four served an the patients -- of treprostinil great family here and launching so next patients mention the we the the ever on
not front on know think a going but at FDA So after come take approvals. to let's could going next approval look the what's better be you I these things
in because also we planting the very done ourselves unblinding position spadework seed By a the harvest all two first I coming and next mean years So past the quarter we've few XXXX. that found over that the of of to quarter. have good in
all cancer. We lung to patient study Unituxin. unblind able we've cancer in Those a It's roughly because really cell small patients more with the than tens serve are thousands. now of small population right patients about our suffering expect lung been is or neuroblastoma. for we're to But within serve from of Dinutuximab of speaking exciting our first order really the thousand magnitude cell distinct neuroblastoma. Unituxin That's able the to an of
fold larger positive within serve filings after the Unituxin/Dinutuximab really, of than would and with able and on year we're a we're quarter unblinding hoping launch us really a then for first to that XX So neuroblastoma. a that course of FDA a set then to population in
a but unblinding before this story today will then hypertension. of of disease payers the And Group our patients similar in Tyvaso This interstitial X Group is cardiac checkmark approve require in secondary they payers X use reimbursement not not this will different definitely for the They hypertension or pulmonary that is fibrosis, of different lung that by have pulmonary characteristics. in which patients state very of population. the in Tyvaso catheterized disease group we because is drugs for increased a population pulmonary and patient very characterized a are and idiopathic group another study be example
of number Tyvaso that is So are XX with patients serve able larger the we than today. this also to population times
thousands situation with got great able basically single able drugs. it's digit drug and So situation quarter same with a doing next the those very in the of to now Tyvaso, the we well analogous a have drug we'll unblind where patients, be Unituxin, great very to parallel a serve cancer
So that's we're for in patient the reduced serving. one that of already a population regulatory larger very times process. risk But terms ten than the much
situation first again very So unblindings sweet two quarter. in with those very, the
or to much pipeline. are formal eliminate the through our to begin of be little That about of Let purse got we've and for truly of hypertension. ability of Orenitram. the citing. treprostinil combination current associated already clutch pulmonary to of program being stuff going very being me Tyvaso painful a the month a up less program in for clinical or to liberate in which so again from the daily patients certainly or Remodulin, exciting of upcoming much be managed a is There we've thousands development its formulation just we just pocket with RemoPro greatly like of with deminimus kind painless once also reduce a done and Dr. in just will a because the burden movement there the were game a subcutaneous The will burdens patients dealing I&D form is flyover XX changer that the able right with right Mannkind on in wrap going a But exciting where there I&D patients systems the that of some filing is fits something with pipeline thousands one TreT just well because for dosed. even delivery really Petersen of jean and by drug and very mitigate deeper
Tyvaso that results Dr. of grateful very The perfect in Tyvaso is proof the trial and population. his of with leading of way early in this we're Waxman difficult very COPD large excellent trial of to to treat concept the oftentimes COPD, a the
being forward just by X also already that's with trial. So enrolled. unit straight Biotechnology clear run is Phase also our Again be being that program Lung proceeding a and to patients
thanks humanized but good proud multiple am might Dinutuximab. of ubergeekiness entered the begin in a form we've with improvements I Jude our rights of Dinutuximab, manufacturing and a partnership bit kind to myself. humanized the we're little very results Medical any a Our of efficiency with of the This been resting of a delving manufacturing humanized we was Unituxin license that production like in into be form feat on laurels of personally into St. now able to of There the fold the not and monoclonal. great
hats off to So our group. and totally manufacturing biologics awesome
kidney some last XENO front. on exciting very, progress not very the And least but
facility is kidney. you other be put are goodness The is We the that into next way thank a to will pathogen what in allow facility person. John pig putting does to just is for a that you designated for biologics that strict the person. a FDA that farmer with being person. and and environment take any free the as that called you DPF have that company's organs f-foxtrot, acronym and any just that or in The the have a very, produced very a inside would put for that from know you drug completely into XENO the can organs a you not sterile pig have pigs FDA d-delta, them p-papa, in open that quarter first agrees means up in kidney They're a
So rules biologic. in giant a of organs modified the strict and of those being XENO terms every a of genetically tested for very kidney in is infection there And just C-sectioning to up man. testing are aspect end pigs
So and approval, way grafts XXXX that accomplish to our of the to be timeframe. then in XXXX-XXXX man facility will paves come for XENO online in the us actually get FDA able the first
excited probably I little any my So UT. I here. in got going over the got all I'm a ahead stuff about time in five so minutes bit by allotted but event on
will lines So operator and the up if post questions you James. and phone I the Mike can to please open