us Thanks, Louise. for Welcome, and thanks joining today.
design about I share activities. We talk with for certain on align want we X XXXX deficiencies from address to significant a sulopenem oral move worked FDA in complete their We trial for July the and made additional of progress our an FDA to XXXX clinical the received sulopenem the to noted highlights some letter clinical to Phase development XXXX. in forward. in XXXX response
new the SPA conducting assessment provides company's potential and out the as X support the drug sulopenem. The to the for in set the Phase necessary design analysis planned special our that We agreement FDA. clinical submitted under new resubmission are a FDA, adequately the protocol with objectives to the the of SPA addresses trial of application agreement trial, oral protocol clinical
X for comparing Phase expected Augmentin study REASSURE the subjects. as oral designed oral REASSURE of oral patients. approximately to sulopenem susceptible new a the is clinical enroll our reminder, X,XXX trial is as enrolling The Augmentin in sulopenem tract population brief urinary a As non-inferiority currently is uncomplicated trial Augmentin to and known infections treatment comparing oral and
of five be is oral primary twice days. to daily day daily trial, randomized receive at overall response, combined response for oral endpoint In the sulopenem five the patients REASSURE clinical twice or The days, for will the XX and Augmentin trial. either microbiologic
if first second the FDA our half of XXXX, in of in successful, half resubmit and XXXX. enrollment the the complete we'll NDA to expect We to
from XXXX complete note that the resubmission in to urinary new our should July area the FDA's important remains and the occur It's all six tract treatments uncomplicated the review deficiencies in for of from the If high. resubmission. months addresses infection therapy letter receipt FDA, need response then received action oral we in
large currently approximately market the challenges effective U.S. leading the including quite prescriptions XX options. new treatment seeking million efficacy is oral face almost annually, available increasing and physicians in community with Although treatment safety resistance, options all and
these sulopenem granted that Iterum probenecid directed a bilayer patent composition U.S. in uncomplicated substantial tablet pleased oral the allows method runway very sulopenem the are provide of protection which infections. the bilayer protect etzadroxil of oral directed of We value urinary in into patents, use of U.S. to oral Both and treating to single XXXX, the including sulopenem, tablet two to share multiple has one will to tract the diseases, which been a patents sulopenem contains in of of for one and
International Outside U.S., Europe, America, sulopenem opinion including of the Search claims invented. that South composition indicating of parts submitted pending and which receipt the directed the Japan, and we of patent the the written applications, have novel Authority, in of bilayer to oral tablet China, several are following of were
areas an evaluate important could to unmet alternative treating in potential potential need and is an continue new where be patients. those we there sulopenem medical Additionally, where
We and plan will share further. details as when this develops additional
$XX of position million cash remains with balance Our year-end solid as a approximately of XXXX.
to short-term fund equivalents, our current will and operations be cash, our into mid-XXXX. that expect able We investments cash
in the help have to enrollment forward penem are to need market begun the we bringing in trial looking new oral the summary, potentially first a aligned serious to and the order pleased REASSURE clinical our are medical with community. to address FDA in In and
financial additional turn details I'll our results. to Judy Now, the call for over on
