everyone. by is This a Hello, late-stage we start in indication under a for by seeking granulocyte-colony providing novel of regarding our the long-acting going asset and FDA. I'm active Kurt. chemotherapy. neutropenia ROLONTIS, receiving patients the are update to stimulating an for myelosuppressive is factor which brief cancer Thanks, treatment review
the both duration of studies, robust endpoints. met controlled they of pegfilgrastim. interaction having severe The to We in pre-specified large file date endpoint non-inferiority safety The review typical are from BLA all XX data FDA and pivotal of ROLONTIS the randomized trials. year. our with October was and on of neutropenia met similar profile this In the as a our two is PDUFA based remains clinical secondary
chemotherapy. when of with week, ROLONTIS to The Phase announced a patients early will in same will we of is randomization evaluate patients chemotherapy at dosing Last the XX open the is severe neutropenia administered first patient trial points. administered clinical time the at ROLONTIS of when three the continuing. day the X in ROLONTIS equal this breast in investigation different on Our dosing clinical duration to look trial cancer. be with Approximately labeled three points following stage time standard enrolled trial as
enhance chemotherapy explore treatment receive way myelosuppressive patient chemotherapy. to ROLONTIS data positive administered well opportunity the compliance day in This is novel could the simplifying us and as a Same-day provide burden managed cancer further scientifically dosing allow to The an as will minimize pharmacodynamic of patients. study the patients reexamine us who neutropenia preclinical properties by as same structure in logistics.
presenting be same-day in model rodent highlighting the Annual our an Meeting dosing preclinical month. will AACR on abstract We a data Virtual at next
to the get closer you logistic the presentation of update date. on the we as will We
Now, let me shift gear to poziotinib.
as XX We are indication. mutation these physician no to ZENITHXX multi-cohort investigate approved effective treatment lung search insertion clinical cancer a patients Exon trial options poziotinib with cancer. in their to evaluating of the non-small and cell is therapies this are Exon mutation conducting among there in XX specific most patients this the lung multi-center difficult of ZENITHXX are for treatment mutation. are and the trial treat for
presented week, Meeting. Last Cohort we at the X from virtual AACR results Annual
meeting, further Cohort change the ZENITHXX we X. data to changes study. of of pozi's from announced on strategy some Following our understanding our This are result that
at when there undeniable our plot you reach As showing waterfall stated even activity, the did before, not primary look though we is responses, endpoint.
than to have and at prevented once some reductions, which high once-daily demonstrating we interruptions per sort day. frequent dose patients and half-life led when XX described from is its week. of less potential. we dose the to hours, believe that of might the dose all We a too three two hours, dose now of from the The at full poziotinib XX% approximately believe to as therapy, drug XX-milligram been last administered drug is times administer generally interruption in of you half-life have discussion eight Typically our
Cohorts impact various the ZENITHXX amended As dosing a amendment result, protocol through we schedule. new This will include to X. have X
are a X enrolled. Cohort As reminder, fully X through
new into and will Cohorts X, study or entering X-milligram dosing. the will Cohort XX-milligram coming For receive X X, to the BID X-milligram be our An implemented patients day from randomized once a amended have X, or that X-milligram the trial their and patients new this additional BID. analysis steroids sites successfully more into of use with earlier was patient some Cohort learning supported protocol. we X of change In
concerns of about using the efficacy. lower dose loss is a One of
Let same me dose. the remind daily using that actually we're at you BID, X-milligram
of events of Cmax this However, treatment-related a should our our value. that dosing will staying at BID ICXX both allow dose trough that us achieve pharmacokinetic while not frequently profile. reducing losing suggests a pressure level critical PK are the better above paradigm adverse function by deliver modeling to anti-tumor goals,
Cohort for during to half the release are We planning results second results the with Cohort year. mid-year X of the X for
cohorts to is readout. timeline challenges X current Cohort of Rapid you for a for an exact difficult the company. enrollment priority it me key for BID our pandemic in the data make give The
the and challenge pandemic. However, of team are COVID-XX the our to focused investigators despite with is urgency motivated act
completed Cohort Finally, additional analysis data. we of have X recently
Virtual late The in an activity of in non-small previously-treated responses X poster subgroups various EGFR lung cover upcoming Cohort cancer and of ASCO at We the will will meeting cell in presentation XX durability have oral Exon patients. presentation May.
it turn Now, Joe. back I'll to
