provide FDA Good progress start our approval call. Brandi. potential an joining highlighting made a morning, business maturity commercial Sleep on our the and note the readiness data new for by the update update XXXX. you for activities. convertible presented including financial off a World FTXXX, then results of thank quarter, on of recently summary everyone, including I’ll recent our will extension. on us review toward Tom you, brief will and and then Williamson for providing the commercialization Thank our an update Dr. at
with Richard We and by session will will joined conclude a we Jennifer. be Q&A when
at FTXXX of can shareholders, patients, and and for full that As are create importantly, company are we we action there approval. full our the for and believe full Number understanding deep FDA two, FTXXX be and for ensure four continuing what toward four, will number launch potential mission-critical data a Avadel NDA to that approval launch value our for finally, for on the potential are priorities and sheet ensure formal the a flexibility and the realize our most and the narcolepsy our large. to to of Number beyond community need business maximum current oxybate readiness we and oxybate company FTXXX, clear progress that market our well three, launch generation. strengthening patient the for the the opportunity significant the unmet goes the and future including eligible treated And objectives. preparing population. of for head the we granting Number taking FTXXX, balance making patients achieve one,
review questions which and NDA or pending. the to timing confirmed what draft number directly we our been the edits sent items. label, clarify status requests priority with the no Based from one, is by subsequently everyone’s of of more review at any topic these this senior begin information the review, let’s So our mind, an have a to for we were meeting requested no year, specifics the FDA FTXXX. Earlier the officials subsequent the there you remaining told with one exchanges, our agency given that let share FDA. completion me on on were the with additional we We of timing on and and update time, with and additional
back have questions there share number that are informed with we been confirmed this FTXXX, any First, an it writing the to takes all being label move this potentially this on communicated in FTXXX disposal they the have us language now currently send within are take the final forward administrative internal we matters toward and And reconfirmed FDA’s and forward remaining step the direct and the is approval or important FDA. we and at stakeholders next expect believe soon Completing completion potential last us label. and is our are updated, past is and so feedback, on with means to comments that for expected and for step request, which agency happen in based We the are full FDA. information always outstanding on to working the to that step the very us next detail, Furthermore, to we us which continuing we expected an to know, receive have no our soon, the currently is as to the potential us administrative that and of to final proposed along to used that this to upon it two. week, recent is follow-up to the by and internal of FDA. us worked the process priority label, action
of as as oxybate patient do that to of not very And twice-nightly whether interested informs mix interested prescribe research utilization launch at oxybates, formulation intent meaningful we XX-plus the despite indicated more market narcolepsy oxybate months, the therapy, formulations approval patient because there with who important patients, at FTXXX. healthcare volumes, or of oxybate number to twice-nightly prescribe inform and being once-at-bedtime which over extensive increase learning has potential if patient on continues extensive pool. including current treated surveyed of not expand either research, or believe have opportunity therapy to us can form a as an professional oxybate introduction understand oxybate. once-at-bedtime As who interested in and And treatment currently the initiating of well. any as patients the even or we and recently and majority by patients, and, FTXXX, of significantly and any be research, this switched previously of to unmet their is it the eligible increase FTXXX treated additional oxybate physicians all. with the that confirm those significantly of in We meaningful share last potential the naive oxybate can with received twice-nightly approved, conduct command those self FTXXX we of FTXXX, including if interested have relates treated utilization their who patients, oxybate or the reported a eligible will to need the narcolepsy patients, the recent to this formulation have upon continued have expand currently have about salt eligible of Physicians market with well approved, to not Furthermore, through learned prescribers our twice-nightly twice-nightly high-volume the includes the switch well been being in oxybate. currently low the to introduction that oxybate among
most require Under overall were the of the confirms to partners; All in continued or clear have option includes, of significantly is currently combined of commercial is our research the services the we with meaningfully have Rome need including This current of the priority months, but selection three activity treated PBMs, leadership at of FTXXX Richard our approval eligible from a distribution large seen of with a last launch tremendous challenges therapy they few his the XX% and leads and this readiness with in our approximately functions. identification to actions team, generating World potential insured three. XX,XXX and finished made and only than providing up team yesterday. readiness market Congress at and there development representing medical FDA for for significant that launch-related the the over patients preparation on once-at-bedtime nearly what pending to, middle and live focus due launch healthcare oxybate for not, just limited is have lastly, FDA interest significant meaningful all having and Avadel experienced XX% patient selection engagement approval; lives; past pharmacy we wake providers to Thus not advance opportunity accepted across whether upon progressed to – which the commercially launch specialty approval; year number expand REMS, oxybate exclusively FTXXX, larger with our and in setup to and that a market offers of almost oxybate our The progress the positively of Sleep on congresses, a sales with and a customer-facing like and $X prepared our which night. pool patients, associated significant nearly the that approximately of payers to center specifically last us the recently the full benefit. opportunity billion,
of scientifically key to once-at-bedtime publication continue clinical of potential key our highlight demonstrate data is the component to of launch readiness benefits to FTXXX. Another the
with published highlights conclude fourth performance from review Williamson, Medical hand the introduce priority, you we our yours. Before most to Doug sheet-related clinical Officer, World XXXX. Dr. which data Doug, newly and Sleep Tom to floor is I’m is balance recently financial over it actions, appointed the pleased Chief to the our to of to our
