Thanks Jerry and good morning everyone.
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view to we Before I'd in regulatory to briefly picture strategy of expect X, MATXXXX. see the our I of bigger the outline walk overall for like what you through specifics cohort
indications As MATXXXX. for you'll for working filing we are recall, towards NDA three an
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relevant any we all treatment. and administered package overall with intravenous Third and their amphotericin the official feedback B meningitis oral treatment This cryptococcal share will for potential X, is FDA especially registration month for next indication with for an next for cohorts the to X for need meningitis eliminating potentially plan year. early be and induction cryptococcal discussed Flucytosine an
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Phase again During MATXXXX six. fluconazole receive treatment continue the with to cohort patients consolidation week in X through
for cohort decisions that be the that on well. of would review are formal the end the enrolled, enrollment in cohort and fully pleased that that cohort Based full We the convene of and DSMB of the reported year. schedule, data X now the patients is completion, will expect we ahead and doing enrollment progression very are is before current the a to
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in a no initial counts of within of activity the First, MATXXXX MATXXXX. reduction treatment fungal with days five fungal antifungal in indicating growth first potent increase
of trial. activity end critical the above the fungicidal for than endpoint X.X, primary this of induction early the greater at Second, threshold
rates the published in historical phases greater Next, consolidation continuing induction XX%. of replicating than MATXXXX patients fungi during of or is which the XX-week therapy, absence Achieving receive of all treatment. to survival early sterility either
of cohort progression signal kidney X that and attributable overall MATXXXX would each evidence for announcement the treatment toxicity breakthrough recurrent without MATXXXX profile DSMB no has achieved. approved infection to of positive strong have been Next, to these a that safety during or finally, An be MATXXXX. an objectives
to pleased progress. am now with we Turning I to share oral our nanocrystal to make amikacin lipid continued strong also you MATXXXX, that formulation, have
As is last formulation. we conducted we oral are patient ascending in dosed first and an This dose expected XXXX. of results U.S. announced half month, being single in the study clinical the amikacin trial our of first optimized a in
toxicology we necessary Importantly, of the ongoing July. in continuing parallel FDA studies, the clinical meeting conduct which are with in was to to studies, our focus
of And We Additional longer-term on of you longer update longer indications support these turn All over remdesivir. our to update for Mannino favourable programs the pursue I'll Dr extended to infection, inflammation. eradication profile therapy. clinical extend hold an of MATXXXX. of long-term date Raphael with for and toxicology that requires clinical continuing leveraging or our studies other progress require in platform LNC treatment forward early MATXXXX who to for in to will for active safety courses of and platform of will infection the other durations us data treatment the the studies ongoing to the studies XX targeted also the MATXXXX Having program, the call to for may potentially the on continued look available hope to provide toxicology the delivery can development that, for drugs term MATXXXX which and support longer. are of X to months planned future of completed XXXX flexibility even NTM MATXXXX this of infections Phase providing you since our be site with with work planned