Dr. Remy Luthringer
date from our joining news FDA everyone. I that NDA morning, good begin like filed program. on of received today. was our and us confirmation about We with April on XXth would the the Geoff, Thank and planning you hold of we the the that time of to you, for this great roluperidone At Thank with February the committee. goal time, received is advisory review review XX, standard FDA confirmation line to proceed not a an on Xth a PDUFA XXXX. that May stated the will it
defined fight Type noted The issues risotto which communicated they FDA potential in later FDA’s already had in review Meeting Those and in I cited as in March the a the also issues. discuss C will moment. XXXX, that under
novel has Roluperidone straightforward not this action finding has new and a mechanism a been indication a of process. in
let you the additional with So me provide with in some our interactions insight recent agency.
for Negative commented and to notoriously NDA Dr. schizophrenia symptom of could revolutionize as the of treatment and our approved difficult negative treat treatment are of the symptoms filing Harvey following schizophrenia.
underscored is drugs to specific no a drugs functional lack improvement U.S. on and importantly, of benefit the by my and very the currently that that patients. translate This the of symptoms have in to knowledge, any there best approved symptoms direct schizophrenia, treat negative development these and a are of in in into
on disease-related negative have While of Furthermore, into as and directly of studies to translates an measures have and improvement to been late-stage shown negative other symptoms may the two positive effect daily symptoms symptoms. consequence improvement shown of be improving specifically of in side the development drugs related function. antipsychotics, a reduce in those negative effective none our that symptoms
knowledge, daily roluperidone only negative symptoms, functional as best patients. amelioration has of both the to shown consequence, disease-related that improvement my Again, of is and the in drug a
beyond negative documented drugs that least, literature dopaminergic is scientific it drug-related worsening are that disease the brain had well of in the symptoms the not in related. symptoms negative may cause block but pathways Last antipsychotic
trials. symptoms which in of are a been late-stage that to have well-identified our demonstrated specifically Roluperidone monotherapy both to intended subpopulation in been patient has relapse is treat used prone clinical negative isn’t in as disease-related those
of one for chose to raised issues by a deliberately roluperidone intend we we FDA monotherapy, patients development, on position the as a as began When is be clinical antipsychotics. While roluperidone we potential roluperidone to use its monotherapy. prescribed
practice, chose The personal We of clinical diagnosed that of substantial an important lives. highlighted manage this therapy symptoms KOL feedback do to whose positive my as symptoms, number need leading in population. their underserved antipsychotic approach based both and in patients not experience schizophrenia negative on who normal drug capable but continuous randomized
the As recruited previously clinical we in mentioned, that these trials. our patients and studied are
moderator symptoms. that do not to those, around XX% a Of schizophrenia significant the antipsychotics to with positive XX% a patients symptoms. require to negative We of estimate diagnosed and stabilize show number severe control
this and Phase Phase controlled roluperidone. Xb Supported NDA. submitting well of included trials of the XX-milligram approval from by patients, our these We NDA, for that that group X and believe of seeking an proposals studies data the were well-defined our submitted adequate we of
The XX included included and XX-week placebo-controlled Each overall data from results set a doses, XX-milligram placebo. period two was and study comparing monotherapy to milligram. roluperidone double-blind
did well and for The endpoints reach the six study Phase the and statistical Xb endpoint from nine open-label both study. of X.XXX achieved study primary most not open-label XX-milligram. phase for of X endpoint, the Xb positive Phase X doses. of months primary Phase a of nominal included on as was as secondary significance exploratory for XX-milligram, P-value the and Also study the but from months the extension was data the extension The met the data Phase
declare at P-values X.XXX dose fact used due not must arm show below are finding a P-values the P-value primary and that achieved. P-value single to X.XX aim a to dose declare that error a the only study the show was in positive that Type X both positive only or this must nominal doses trial in below a to correction The a
showed to secondary roluperidone significant placebo functioning severity key at doses. measuring nominally endpoint So both of compared statistically PSP daily
that which potential issue is One final countries studies have is the conducted. our in with extensively studies and has the discussed regarding point our as raised a which FDA mentioning, were which we worth FDA
the as disease Europe. not does where where live. in Phase country-to-country, study from the they and are Europe vary exclusively symptoms the same same X of drugs included patients with the and both irrespective enrolled from the study a We Schizophrenia demonstrate treated patients Phase U.S. Xb
European The actually the had measured and patients secondary symptom in points as has both the roluperidone throughout U.S. and Phase comparable end X scores the our key study identical by primary responses baseline to study. patients and
would patients negative we to effective like It’s today address to schizophrenia. many symptoms we questions. personally agency the I that and to NDA thank for with to have we discussed of the our continuing find FDA the for with here treatment for and their forward critical reasons have safe review to an opportunity look work
of coming months. in of the you. Thank our progress to I all will stakeholders continue update Minerva’s
turn for financial Fred now to over update. will I it the