for Good you second earnings joining afternoon. And call quarter our thank and business update.
I up we this call Chief questions. Lisa and Trevi’s will is Financial then remarks, it Delfini, on have Lisa today prepared me for Joining open some Officer.
During indications. the to continue advance our Haduvio and clinical for quarter, we development our plans’ chronic cough
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our to two in program. planning chronic IPF this development studies conduct of cough are next We in parallel phase during
will doses study The first active that is a three trial Xb forearm Haduvio ranging and phase of dose placebo.
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in leveraging from the are in study. our learning’s RCC as plans We companies own other our design we development
at the IPF both the and with cough mechanism oral data quarter, presentations as lot Thoracic medical Phase the to attention American American Society X during a continued garner Conference. as Cough Our well of at conferences meeting,
the published data Evidence. had results also CANAL from in NEJM trial the We
the this speaks cough difficult think community’s to across program patients I and these our in in medical unmet to the IPF indications. of need the interest medical cough importance treat
other we of is work prurigo PN. or The indication on-going the nodularis, have treatment
upcoming are dermatology was We that conference. with intend study currently analysis the open from an associated at the to data and completing one-year extension label present that data PRISM, we
meeting the to X We the expect this to plan year. later determine with will program. we steps Phase end to next which an for seek we request also After this FDA, meeting,
or conducting is is abuse the potential an this U.S. study. parenteral that the is Note butorphanol, in which of abuse we The unscheduled the agreed which human of study, likability this Schedule DEA. drug. filing. a upon the compare version by active potential oral comparator, are objective is or of the nalbufine NDA a Butorphanol for IV to Finally, study for nalbufine to Drug Enforcement is currently required Agency,
comparison nalbufine. with for study first parts, against The dose the in and various the two to being objective for part characterize is appropriate doses butorphanol oral a conducted the choose
We nalbufine second have the the of the and the part have selected and study. for I doses study completed butorphanol of Part
to FDA this get comments. to data We have the their submitted
is relative three of doses of the portion and crossover study butorphanol five-way placebo. the and of determine placebo-controlled dose to The oral randomized, the double-blind, second a abuse selected nalbufine to of potential active, design
work to of the single-source IV a butorphanol, the was secure is due shortage working However, as nationwide the the study U.S., study. this the from there in in plant the portion of delayed comparator supply bit, a but damaged supplier then drug We were recently the now is that IV of commence resuming are the and FDA will company final the the tornado, on will conversations. study. to portion recommended a butorphanol secure before need from we through to to we doses, have Once able the input and let matter we supply
opening Importantly, studies this support study cough critical our for any sites is of strong and trials. we path planned closing, three enrollment. running getting not these focused on to In the on chronic clinical and good up are
initiated timelines. studies are We and will expected and study announce design provide details as the they on more
then questions you may to review up it any we turn now will to Lisa for open it I over will have. financial our results,
