good Thanks, everyone. afternoon And Jerry.
FDA the technology of targeted, of pharmacokinetic minutes profile productive the MATXXXX, life-threatening while also toxicity and development feedback administration. IV to platform advance its collaboratively delivery of orally desire IFIs. April. of for written of a developing FDA novelty unique also the mentioned, impressive held in that Jerry the believe without benefit amphotericin to a form in to with acknowledging from its work the expressed very patients amphotericin official We meeting with with for received B B safe, the administered our LNC associated the recently continue treatment sees us with reflects clinical we As the agency
antifungal Importantly, FDA encouraged guidance The pursuing by for barrier a a demonstrated platform us cryptococcal for amphotericin able in the was IFI our our the in EnACT meningitis, impressive in which unprecedented outcome that provided registration form indication. B across the X from well-tolerated LNC survival results the agency with to MATXXXX broader was oral oral deliver valuable therapy. safe, with Phase trial blood-brain
be the to bridge support challenging that trial as approval since in or necessary pathway support X a treatment a During a bridge Phase administered our streamlined solely meningitis broader to on pharmacodynamic to us necessary pharmacodynamic with fluconazole. MATXXXX establish combination FDA focused cryptococcal larger meeting, indications would advised flucytosine XXX(b)(X) IFI would be
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development strategy to pathway. MATXXXX, for the result We clinical the expect label efficient most utilizing this broadest possible in
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under IFIs a X portion a to the Our qualify we Phase this review leveraging allow of cohort We possibly designation, for benefit orphan the Fast incentives expect U.S. with the bridge XX to pharmacodynamic aspergillosis label from broader to comparative capitalize and including trial. Track in upon could to justify expansion group that protection to of in the of years and to will of XXX(b)(X) exclusivities plan XX establish FDA strategy IFIs EU. pathway as drug QIDP the the and priority under continue well in as for years the exclusivity bridge
collaboratively submission and this Phase basis. with FDA an review revised example provide in protocol and for This another a the working of FDA month, perspective of X agreed timing to We FDA later the off-cycle from comments on has is and the this to protocol us. us finalizing benefits are process
margin We aspergillus also of trial, to overall and study acceptable impact in completion. cohort this expect timing size for the on main the collaborative this the will for the which agreement this cohort spirit directly impact non-inferiority
During use our the access our program. clinically as meaningful receiving outcomes also compassionate meeting, expanded patients from recognized FDA part of MATXXXX
and/or Since August numbers fungal inbound safely several renal beginning the classes in of the experienced demonstrates toxicity at Children’s on data patients receiving other cases. or University among Hospital requests program invasive of effectively of behalf amphotericin case limited, of of most the target Nationwide received to azole B Institutes are Health, Johns physicians this challenging unable and the are have ability antifungal. not While have have or to year to the we responded Hopkins Michigan, and of National clinically last others MATXXXX infections eradicate in IV while from even significant who tolerate
in various of sinus, fusarium, including and with brain and candida, with have including: patients part protothecal infections program. These our tissues central life-threatening across infections MATXXXX fungal skin, presented have patient, from body, reasons diseases coccidioidomycosis, been lung, with nervous toxicity. MATXXXX with the various aspergillosis, have seven evidence six infection or date, the seven or five resolution To ranged to system. discontinuing bladder bone, of treated mucormycosis, rhodotorula for with the renal treatment two treatment any longer monotherapy to unrelated have no of Treatment weeks administered successfully courses Off completed one MATXXXX. the patients with months as as
for normal for further to electrolytes function any patients after return Renal to MATXXXX supplementation. need no switching the with
highly access treatment hospital case mentioned. Jerry MATXXXX at note, a Of of and Additionally, on pace presented all impactful ECCMID has expanded study an the our increased for were after outpatient basis. last discharged switching request inbound from following as month the soon received program to
where of MATXXXX continue meaningful trial outside the patient additional support of requests will use and opportunities clinical generate to to presents clinical compassionate for and sense setting. for We identify the access makes the data
now Terry Ferguson nucleic acid the call turn our to Terry? like programs. to discuss to I’d over Dr.
