is sulopenem tract In Klebsiella a the ORLYNVAH, oral January, the was And infections caused brand resubmission, women our bilayer Augmentin advisory XXXX I'd successful very year for urinary was bit of name recap meeting. who oral or a antibacterial pneumoniae, joining have a to only like product.
ORLYNVAH Thanks, of talk a tract Iterum. In September, and October XXXX milestones in brief Proteus and XXXX. States. in E. the our provide for had thanks us Overall, good Louise. in key Difficulty] no by XXXX, first sulopenem and FDA to ORLYNVAH trial of activities alternative women approved today. with we for for penem approval indicated submitted or NDA III adult we in positive which clinical generated Mirabilis urinary limited adult microorganisms, Phase uncomplicated treatment together Welcome, in efficiently the committee about is in treatment results oral the REASSURE received designated United our [Technical April. uncomplicated oral infections pivotal coli, and pull options. in comparing for
million rates uncomplicated decades. first States was XXXX only and high penem in market, in product other in the and majority to first United prescriptions the The excited enter oral approved in widely urinary is tract as in infection branded tract annually. as market used rates will be The quite past so two can were and the ORLYNVAH about resistance Now those XXXXs. urinary XX%. approved in the you the having to these for market uncomplicated market nitrofurantoin, approved XXXXs the as XX% why rates a has approaching over oral ORLYNVAH run I'll we time infection second products FDA-approved the led and an with the of the use tract the to XX estimated and large for treatment leading U.S. generates resistance products product infection XX urinary products ORLYNVAH the years.
The over the in and in few tract the potential are in market. resulting extensive the share comments the urinary rising uncomplicated is in potentially of most uncomplicated infections
rates infections a to prescribing physicians continuing products empirically, the creates tract for practicing eroded since are resistance for efficacy of urinary over these uncomplicated increasing time. challenge be occurs As most
some physicians as challenges as oral forced for work choice have of all physicians again safety decades, in almost would treating products they to their as therapy agent have Unfortunately, use in may well their concerns like Additionally, use. that the almost that with no been not area innovation create to patients. widely for to used of this agents
that With or older, treat no into options could challenged that other are these of there or that at option safety This who recurrent treatment many elevated there specifically years define treatment profiles are women of have of with as the category available. risk systems. into be who now patients have a that risk as limited ORLYNVAH well patients the comorbidities that women patients have We immune an elevated options categories: are substantial fall believe who oral other with as resistance existing their or history patients patients.
We fall for women hurdles. approval, impact group patients alternative most any XX risk to this physicians those drug-resistant diabetes, Women that their women are given infections negatively many and have or oral following
have of are oral key and that completed Another as the clinical in uncomplicated to important ORLYNVAH patients conducted all U.S. approximately this role X% X,XXX across exclusively in treatment these oral tract the resistant patients in group resistant well. an oral could we significant of patients available REASSURE that commonly and therapy that last almost was antibiotics. area urinary safe play are patients of our isolate antibiotics. had all used trial, alternative an in to new efficacious a pathogens infection year patients, these need treating found In that
GAIN X ORLYNVAH, exclusivity of the years FDA October market exclusivity ORLYNVAH the total the date a additional years of XX XX, the from protection formal at for As with from or marketing until of under we of has Act, for look approval XXXX. confirmation
covering U.S. patent for matter. into patents U.S. both method issued XXXX, with ORLYNVAH provides portfolio and composition of protection our of use Additionally,
of ORLYNVAH that capture products that We the should have submitted for have amount patent equivalence market with are very without approved patents with U.S. ORLYNVAH in Orange pleased U.S. listed information Book evaluations.
Overall, the FDA's product. generic in a for competition potential X we're from to value therapeutic protection drug
have, issued there in to patent Europe addition of other a and U.S. are pending the the in-licensed applications In including number and jurisdictions, we and China. patents
we a are As to XXXX, enter note. few items there
sell, announced are our our the that approval remains off have rights with to continue value stakeholders. priority strategic transaction. advisor, potentially key or of those to otherwise dozens with maximizing for since engage the and strategic the interested will process conducted dispose financial outreach have companies our to our Along goal of to with license in we ORLYNVAH Our and previously
adviser whether our neither or of such to in consummate a assist favorable nor will begun efforts whether strategic Board we appointed transaction Iterum Board, to commercialization do the our financial in sufficient a that seeking activities result the to highly plan definitive of ORLYNVAH strategic foundation raising receive to to the a in physicians of value acceptable commercial in control are ORLYNVAH, options for with on definitive front process, capital alternatives is offer or As the any other offer, evaluate engage strategic a maximizing is parallel the to terms anticipated evaluating targeted the to various the capital which as to possible. have in if to and in include raise of launch as as for to to as support to subject pre-commercial or patients available ensure may the made develop soon partner order product directly, the ORLYNVAH.
We we
and side, the with of end their repaid the the our due in have principal notes On January interest at we terms. under accordance financial exchangeable
second sufficient our currently half activities, will into XXXX. we operations expect based planned to our including pre-commercialization current be Additionally, operating plan, the cash of on fund
Matthews, Judy CFO, for Now financial I'll call turn to a our over the update.