great we everyone, third as several discuss us results. third very important thank which Overall, by the business Peter. you business entire to provide you, morning, across Good we quarter and our accomplishments. our progress the during taking today XXXX made time quarter, Thank for marked a and join was update
aware, reviewed X and as to of following in Part commenced recommended to objective is milestone This Taking and this necessary the pause a data for in and completed the great steps the Safety for October, initiate forward. we significant and company recently, Data key the the the in everyone study First, study, MATXXXX temporary More in DSMB, the company was portion dosing, study progression COVID-XX, a was the the EnACT as we and dosing first all cohort. patient cohort cohort unanimously of Monitoring Board, precautions XX second third quarter. with moves provides July, patients. of a independent into the first or due EnACT optimism
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the data from report first to study XXXX. this track on of be to continue quarter line in We top
X call. detail on the the into will half our development II of are program more to fully our Lastly, MATXXXX, Phase I we first FDA aligned for end-of-Phase FDA the elements with later go successful had them meeting XXXX. on which the we in a program with initiate MATXXXX and of expect very interaction recent in key and
MATXXXX, the nano-crystal amphotericin of highly the or with spectrum explores formulation both Phase maintenance the distinct antifungal study, development drug, lipid the for The MATXXXX National is of has broad our X begin potent in II EnACT of in which treatment induction study, of LNC, supported B, parts. in Let's meningitis cryptococcal in patients use by Institutes which currently EnACT Health, Uganda. and HIV-infected financially
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efficacy Thereafter, In the of unanimously the favorable patient both second cohort. additional the in discussions Based of believe we to combination cohort the reviewed efficacy and and data weeks. first that this our October, therapy to principal DSMB safety to of patients safety recommended the given X advance and need patients patients. an vulnerability a data DSMB on maintenance EnACT next into would forward with see treatment the and from XX order for the continued active investigator the moving MATXXXX population, as cohort of study
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on to our commentary the Before progress LNC moving that of broader COVID-XX provide discussion priorities to had of to impact would we continue ongoing like we despite where collaborations, on our a brief of good the strategic platform collaborators. some make MATXXXX, short-term has
formulations to with in agreement. continue very We per work our molecules closely Genentech of developing existing multiple
terms of are we limited commenting seen, under further although We agreement. are encouraged that the we by precluded have data the from
for and Genentech potential is which of least to-date at extended platform our both organizations benefit the However, recently approached shared us indicative believe by continued LNC progress enthusiasm agreement year, and technology provide. for we our another can the
and explore through aggressively against we to to be will soon. LNC Institute the COVID-XX National continue that participant opportunities Infectious in our We the a and remain platform of Disease utilize fight Allergy optimistic meaningful
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will I MATXXXX. to turn Now,
of at that important there mentioning. X are As milestones worth I mentioned the call, the are our beginning third the quarter program very during MATXXXX for
quarter in our trial will comparative PCSKX we acids. and second in effectiveness study omega-X data eicosapentaenoic as COVID-XX, of indirect of presented the top MATXXXX, markers compare as MATXXXX omega-X trial Vascepa. First, triglycerides clinical direct levels head-to-head in the effect continue blood important lipid enrollment we of XXXX. other therapy EPA, next-generation other such directly line ENHANCE-IT, and challenges and versus first acid, and this as completed expect well by their to This from prescription our or Despite on crossover fatty Vascepa's reducing
the other study at the any show Vascepa to omega of stages overall right the profile we again exactly exactly of complexity including drugs. versus the ability of prescription differentiation market, is the to demonstrate only generic right copies important. We Given continually in omega-X Vascepa X, superiority MATXXXX the evolving superior the to time believe potential and and extremely of those are head-to-head final
without following to Second, of filing the are is registration upon X Phase pathway a efficacy for aligned Phase program to MATXXXX treat submission. or support requirement to NDA official work; of flexibility approval to with XX-week directly initial believe any above. the for for Three, the development program Two, The in safety include: FDA go clinical additional data needed main elements an X steps NDA a and review an we at requirements which for single II the severe end-of-Phase a patients one, next to in and and XXX meeting of meet indication study the we minutes, on into key an patient X study triglyceride totality Phase levels support severe XXX(b)(X) with hypertriglyceridemia; agreed hypertriglyceridemia, regulatory
program Phase to MATXXXX omega-X for data, initiate both We track and several XXXX. prescription ways continue provide to meet additional other evaluate potentially first half X to we from our of requirements on the remain differentiating drugs, these to MATXXXX and clinically in
that physicians to branded to potential lipid competition, results quarter. near-term for and now for EPA important clear the the the our with believe MATXXXX direct who we to and financial indirect benefit to our we Chief study from of goal best-in-class Financial discuss triglyceride class. Keith results the market omega-Xs to and to call and of And ENHANCE-IT in impact rest will MATXXXX Vascepa separate would like of the designed differentiation such over As head-to-head to from expand markers, recently opportunity and the face I on continue omega-X. third omega-X restated MATXXXX and validate was turn and PCSKX. its on in the Officer, generic the educate view the as Amarin the provides first as an our commitment pharmacokinetics continue prescription of Kucinski,
