very us today. for much, thanks joining Louise. Thanks Welcome, and
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date scheduled Committee Xnd, XXth. June We have and July PDUFA an is Advisory for our
about to United the oral sulopenem in addressable like States. moment the a talk I’d market spend Now, and for
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details thinking. I’d with working We’re An to you we’re the plan, finalize potential our some with the current finalizing We overarching that like building agreement. process comment EVERSANA in service commercial still the to a have the place and We currently of our share plan three but launch of of XXX to regarding resources. on to to drug sulopenem. And commercialize key reps where to criteria to expect targeted use we going implement XX approved. currently board sales determine between to and highly get we’re approach commercial a after is
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as With product regards to uncomplicated our where of will to assumptions is we closer be about talk and competitive pricing, just coverage that will to in extremely five-day measure place our a right like know, landscape an we’ll resistance we believe launching resources infection meets Ultimately, you The all a that an that with $XXX would high per to pricing minute $XXX estimate place approval and managed care particular urinary sulopenem take we into we these the the because the to end which of be those to where likely be high price now. area And tract of three managed regarding abundance therapy. At of commercial drivers price. finalize is is in are look is criteria, the field. and many study at of course a is plans. physicians. would this between commercial formal areas If at day pricing level, current gross decile resource. branded that third the will oral, those will wholesaler price a the care conduct acquisition cost, lower and we now the antibiotics indication attractive on be the I’d sulopenem
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our I’d for to potential Now, other attention turn to like indications sulopenem.
takeaway urinary the comfortable discharging in ertapenem an addition hospitalized therapy an on sulopenem time very new, the regimen expand annually primary multi-drug the ciprofloxacin. one is infections arm, Therefore, desperate response indication worked key with effective asymptomatic we we two X.X missed to intravenous endpoint X we million tract stepdown all follow-on therapy. urinary be very these sulopenem efficacious studies, in urinary sulopenem look safe due will the intravenous infections. oral study, infections. background, patient. study, urinary safe to and antibiotic both and infection infections. we’ll need sulopenem believe a similar we here at primary is is infection that to complicated clinical to infections is and allow higher resistant patients message points As our therapy do that the providing comparator overall. to The of to complicated missed study, of tract which that uncomplicated one could physicians measures, for new, sulopenem by beneficial, with tract and perform the the we intra-abdominal complicated the In oral bacteriuria regimen. the oral and/or and oral in And oral studies, first tract in to as has about to was This indications, was stepping down versus feel in comparator the complicated the place complicated large other U.S. In endpoint physicians in one intra-abdominal well treat a did and product Phase In to
are options for today, that hand at available the has of they products. concerns of many physicians shown resistance efficacy have research because due or oral safety not concerns the rising a comfortable existing Our and/or to some with
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assumptions for feedback provide well regarding in around the on to with infection the the FDA the that additional of to endpoints, file work hope this work and indication our to the indication We’re this potential to work, with request next basis regarding in the goal The a going to would year. have this quarter FDA to tract indication. study the meeting and that and second be complicated urinary additional timing Based from obtain do design as potential will meeting FDA for will appropriate discuss feedback determine cost as steps. to us
Additionally, the same infections. is urinary patients infection driven to in our be meeting by a discuss as this have approved with to will be with quinolone assumptions And all year. for request the include the tract infections, uncomplicated expand FDA to second meeting with timing uncomplicated and non-susceptible time. once that we process half label We that at sulopenem around steps urinary our and patients for and and complicated with pathogens, costs would discussion, urinary tract required what tract of follow plan that next
Now, I’ll detail moment. take on couple a a will Judy provide items, moment highlight financial just of more a in to just which
We in first strong by balance sheet and warrant capital a of raises a series very pleased XXXX. exercises to driven are have of now, the quarter
will have which our sufficient allow subject XXXX full to through calendar on to is of first to launch year modest based versus additional approval, launch capital. our year, we into this all and of debt later cash us get our hand. And raising XXXX, Our cash without should on overall get forecasts,
FDA to you the the like major with to our we catalysts infection tract I’d plan share for the urinary discussion complicated regarding have rest with our quarter, this indication. the Coming in Finally, up second year. of
in look launch quarter that We of the expect scheduled third of date remain XXth. assuming the Advisory fourth June in year, we for In we’d lastly, to on events PDUFA And this Xnd. launch is timeline, Committee also marketplace. current to have approval, meeting July all our our and to sulopenem quarter, the an forward
Judy on financial details our for turn to Now, additional to I’d results. call over the like
