our RSV flu Phase third three puts X reporting and continued both NanoFlu. execute call. the to This data we In months data ResVax to for us the to Welcome Phase earnings and from our of all from four third pivotal Erika. X for second quarter programs, data programs. within XXXX efficacy quarter Thanks, for vaccine on quarter goals
pivotal Phase continue preparing With any X for the a to NanoFlu. for and to RSV first are vaccine these trial we in submitting related hand marketing initiate data efforts will very application clinical
programs, We on to to later. will both take more so have of success and that steps taken continue prepare for
have Since endpoints we been participants and promising you continue efficacy while remaining fall, for and the quarter of let by performing saw any following year we would told indicated and the the program participants data can't the day the in compiling first in specific of of third which similar XX% thirds group this observed ResVax is we Prepare one remain think we FDA the licensable remind of this while breakthrough endpoints and XX EMA. vaccine children of level the that quite number third then that mother's XXXX That we we analysis we trial the not the represent historic first know earlier trial. primarily to although us me endpoints we third observed XXX% to year. what two vaccine This First, our into very who's our the number we what to us. the and that that well in participants. primary this accomplished ResVax these looks believe were placebo very thirds carefully to at would look started efficacy of first yet level information blinded the the can was very our with to the for analysis and In we've trial results somewhere and the of and at or end in given are estimate point between two of and an primary range was remaining be of
six the months the representing baby the the be XXXX trial in monitor was We the enrolling life that second final enrolling we through finished the final July. will of we've period their born and over. quarter closely execution, trial now in know mom six-month first when in Regarding pregnant and infants
the cleaning in to Symposium, antibodies this I'm have together and community to have just of of collection data first and in effort the towards [ph] of International XXXX. returned the lock Syncytial effort RSV Respiratory the I XXth from scientific on industry order brought global is and unblinding May the meeting and progress that massive updates meet pleased present to initiated quarter end vaccines, is and RSV monoclonal Virus report antivirals. biannual our a a schedule. which And that team government, We data development going of including commitment academic, database and to
in be trial clinical meeting the data only FDA they competitor leading expect data that followed this a our would New vaccine from which of the two that also early five trial agreed with were June, We've clinical NanoFlu publication improved the the XXXX approval clinical ton which late-stage results. acknowledged available and with website. the last robust Switching sufficiently merited that Medicine in during available and Journal that program, trial are presentations hemagglutinin occurrence FDA Phase for significantly had of X/X accelerated stage As for England responses the adults. These our to pathway older NanoFlu. the to RSV rare could in compared of Novavax will a posters, you recall results, vaccine with trials NanoFlu gears you with started we oral spotlight as with demonstrated all
As XXXX. licensed discuss Phase immunogenicity in clinical in of to the many on pathway topline accelerated know, approval and use study to that to are trial of early X now the initiation in first confirmatory I am or of Phase could and and reach data announce of NanoFlu established we of demonstrate happy designed target Phase during report post with clinical to proposed approval the X unblind and announced to meet the agreement you data with conduct enrollment trials X on a half a X design plan to marketing trial completed X conduct Phase We an quarter well-controlled effectiveness. Phase to end September of our first against trial the And FDA allow commitment full the endpoints of XXXX. in competitor and we the October a the Novavax accelerated clinical
So we and we licensure. regulatory marketing. health us pre-commercial for distribution, manufacturing, infrastructure in setting number following manufacturing process last and of as initiated the payers, targeting four earnings private up government as big help are areas; global post I and critical global our leverage the of pre-licensure discussions, and discussions soon a our success providers, partnering call that to accelerate enable activities cover pharma to quality, activities of sales are have products as described quarterly possible launch and the preparing These activities to us
quality. provide let update brief me with manufacturing areas, So you these of each a on and
we two have process been working yield last the with focus improvements on on a improvements. Over years
our X meet For yields over us global near of both in of our XX the through and to able future we product production levels by to launch development. GMP yields, our programs fold products allow gains, increase have needs will These for the early been to facilities. manufacture to current
us also are magnitude found confident the profit generally should allow to margins to similar that gross industry. We maintain in yield those of pharmaceutical that improvements this are
needed and and the agencies. as from required for qualification manufacturing been facility. manufacturing manufacturing middle consistently now had agreement marketing vaccine in ongoing European confirm on to also with ResVax a data are PPQ commercial details PPQ our we quarter and and requested BLA centralized assurance we a process December manufacturing of These of including ResVax. producing to for data application our track process five commercial for a at of discussed with to known And capable the the remain first of that validated that successful scale. Additionally of efforts FDA applications. meetings we perspective, campaign a reached meeting in have FDA EMA. important We granted discuss the regulatory have with XXXX. we we with program this finally In MAA have on and future components the are requirements submissions affairs are for of major performance provide regulatory These the have
ready the done commercial also of BLA are group in for preparing advisory Commercial that pre-submission including for when and core they in including working succeeded to of preparation that XXXX. approved. MAA both have of of prompting content with These and middle With a up are our expected confirmed now goal meetings CDC's of mind administrative EMA the has with pre-commercialization ongoing a that sets. quarter occur will our RSV to is small the that FDA a in committee part set our group as the submissions activities have activities our of so format and requirements important several we submitting be well clinical if data BLA FDA first advance regulatory being XXXX. We are in we of our applications the the BLA, activities in
payers working on NanoFlu. been branding with with ResVax have strategies understand and the over been pharma close markets vaccines and for have the into our also both communication continue closely to discussions and market years Partnering, have developing We providers we strategies. potential introducing partners to and
divisions large confident While investor companies we vaccine partnering mitigate up for need products our will independently, new with funding with allow to one we product more of or our and launch. us are commercialize launch globally the scale pharmaceutical the and could both for products
to opportunities thick As we us off this? that all and a significant heavy heard the through with yet for time. a fortunate been seasoned manage we long be has done. do team that We're how in-house So you've have to just thin very lifting come have
Vice GlycoMimetics promoted mention this who Senior so ensure like of we [ph] couple utilization our me goal Leecha closely rest These success for quality, for both importance systems manufacturing, get to promoted promotions. and Brian and a recent direction work team that We Senior AIC and strategic and electronic and laid to navigate And of development manufacturing with of complex multi-formation lead lead Callahan get operational we Vice I a and King. of to and for as on experienced for President Brain increased private payer biotech cannot mention Jordi of and veteran. economic to commercial, all that begin very the burden the a and a and multiple thoughtful to to provide want of announce Phase today And take us will to call President, be within Quality scaling fashion. Board of groups have to University Rachel's pharma programs now has for have as in is our the Regulatory in regulatory scale to [ph] President, make has to the the job our across Novavax Executive up invaluable and responsibilities the developing working Rachel that promoted organize and our sits responsibilities us our our Webb with year BIO launch is us lead Rachel timely is we've systematically CMC to late CEO with the global the identified Susan to of the In to of In CMC. was RSV vaccine of groundwork of our attract to been for disease and flu. teams came Kathleen currently member I I'll for the analysis the in RSV. has to vision been stage the joined of Vice biotech the in team. leading ResVax Committee our ago years continues on welcome quality next Directors, responsible working solutions, overstate Kathleen vaccines. an a to people product BioPark. Vice member continue commercial He venture pharma, several the Assurance. In Manufacturing. big a we new and requires capital we to our Jordi in turn we Hensley that CDC after launch. doubt is experience of is effort to President, been has few project regulations. up what biotech We the set CMC line multitude a big the organization taken last my promoted and been product And also has is of Strategy. Rachel have fortunate no Regulatory been has minutes launch. management Affairs impact John to Trizzino. Brian our of X I'd Board. promoted Vice She big years companies as Brian several production all of folks all where of that and in President, experience RSV and of authorization public are group worked of week the currently overall regulatory, development publishing product to been senior on the over for very In Commercial He to Rosen efforts of to and Board trials. has Susan NanoFlu RSV Operation. and Maryland experience strategy, been departments. of flu BLA our will
