be recent for and we'd pleased to financial for quarter results and Then Rob. also questions. take Thanks, any our Good exciting some the everyone, joining to us review thanks to morning, hear first updates.
for thereafter. or cases, segment. our first ibezapolstat, for patients of our the candidate announced C. data Phase antibiotic microbiology quarter diff activities clinical from shortly of we in XXXX, in IIb First, January, comparative microbiome the trial positive I'll lead and summarize some some In key
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for a importantly, III, Phase data reached approval meeting, application to package and the we in Having the key April as February meeting, of regulatory to as marketing granted robust new request elements including, the January, on on to for clinical for II a an preclinical, readiness a we drug regarding well XX. end FDA, agreement meeting was At FDA manufacturing which submitted, pathway in proceed and XX, to our formidable on III with agreement the with program. convened the Phase Phase along of FDA date, on filing agreement information was U.S. the
details morning. further release press will FDA We on this premarket the meeting
and program, College Garey, a and University Double-Blind trial with clinical an the Agency Europe. Investigator reductions April in our of of "A authorization for agency of Study aspects II European presentation Advisory data in fee of submission including Professor Vancomycin Chair, entitled, where Phase In the available Society Ibezapolstat our for is Microbiome Infectious Phase Pharmacy, Board certain www.acurxpharma.com. Treatment data Phase or member, of oral the our Randomized, Europe, seeking be for a We being II Microbiology small Disease year. Houston, our a provided and Scientific XXXX, in ESCMID Kevin Scientific and complete Compared at scientific of C. Microbiology SME the medium-sized for provides approved attended application difficile The Medicines clinical on included The other are support analyses Infection". which presentation II marketing of European to Congress for this Dr. of February, or results and to Principal announced website as and prepared and enterprise we additional journal from publication microbiological to for that prominent and designated the benefits,
Microbiome oral in scientific II rest conferences, results the America, September of Meeting Anaerobe or as of Disease Phase in Throughout Also Infectious cases C. Week, this Conference new at including in or July, in & Society of Annual from the scientific which roll either presentations Americas course, our in available prominent out include C. October. Conference Houston analyses Resistance both, the the later data Society results the is some Conference month, diff or Annual the Antimicrobial of year, of various World posters, diff to Symposium, the and become the we'll continue in September. will ID this International
to drug sites, continued trials, screening, clinical including possible, and experts Throughout clinical clinical number advances micro trial trials. and Phase for mandate. we're III enrollment as CRO manufacturing, U.S.-only the the the to III Phase as To building above first Phase adding support of team quickly Phase way substantially conduct in used site our II more a III and trial quarter, development ensure selection international preparations we
XX date not concern with a of company, Canada. will U.S. size Japan, time our use in to a time given plan conduct lines of We're not most now since line the to our and ibezapolstat costs required is resources efficiently. the have U.K., exclusivity from registration Phase to The trials III years financial our and and exclusivity similar conduct the rolling X need Phase of concurrently, regulatory finalizing consecutively, and approval, in FDA III is our the the Europe, available the trials
have partnership development and transaction the time, continue registration company, to potential a a no will potential strategy. FDA to But to our potential active we an or the ibezapolstat, has become build-out further of commercialization commitments and this plan, III of now Phase strategic preparation We report. confirmation for seek others initiative. At including alongside having for for the partners this our
low of continue initial difficile calls track reported, Ibezapolstat we've to in series a as clinical of ibezapolstat consistently an is also antibiotics of life-threatening infection. for new treatment categorizes also As have difficile results FDA outperform C. and C. classes recurrence. the treatment designated CDC of The urgent potentially threat for that fast a incidence infection. for
by diff yet infection on could burden U.S. of We C. if ibezapolstat, is believe favorable believe reducing health we recurrent cost Initially, $X.X approved, make the come. system, the at which is to the annually. care do best billion impact a estimated
now And you Rob? guide to quarter. CFO, highlights Shawah, our through the our of Rob first the back financial for to results
