Daniel. Thanks,
toddlers. Let's pathway start three, the with on for number slide
to Peanut Viaskin EPITOPE, uses age was square you, the by the toddlers as ages Just was fully known to XXXX. one in this Peanut in original Viaskin remind three our group in June X completed program study Phase patch. which supported Efficacy
XX% with a treatment demonstrated meeting those significant double pre-specified XX% arm. was the lower above that's in placebo endpoint achieved XX.X% well the confidence of was with of predefined in which to The bound compared the XX.X%, the mark. subjects interval in after of less a arm X.XXX XX XX% with of a Recapping effect statistically the p-value Peanut than subjects criteria results, months, Peanut Viaskin treatment Viaskin responder
FDA Toddler news with Viaskin regarding for for steps allergies. were results in of published toddlers We next Journal New from of entitled program. also past written April, good accompanying the featured course, England The in May. delighted from we that food an Peanut the editorial EPITOPE the were, responses This the received Medicine publication pre-BLA the
and efficacy criteria and for therefore confirmed the study did support and met primary using patch As the request original endpoint additional study. the ask not Viaskin agency X Phase safety for our we the specified to efficacy that an have previously square But conduct pre did Peanut study EPITOPE the announced, success EPITOPE. we complement safety that supplemental results a FDA collected from
is in as this subjects XXX four treatment, seven FDA's bring database age with to dossier is in company's position support total the announced December year study group This safety approximately in the intended of consistent which active to XXXX. to on olds, in previously
with in me respect The development or being which and a Thus, FDA children. Viaskin raised Peanut asked specific safety add that. signal more detail has with specific consistent around treatment their program, in been active safety exposure includes to on XXXX, looking to numbers are little Let total. be BLA original toddlers in not any has subjects back for XXX to the wanting we not concerns to assess particular. the The communications in approximately FDA any dating us, in
modified our study, EPIT, by eleven to pivotal circular was modeled be Let's four our enrollment will to are VITESSE Peanut March, olds. patch. initiated the study in Efficacy four is we and move good in X Phase slide now making which supported to in year four, seven evaluating Viaskin X and Phase number in old on VITESSE, the children, using We which year progress. indication
our December years. XXX will seven therapy four to in seven that study safety months we VITESSE, in XXX supplemental the data database to agreed supplemental olds safety to group. safety with also year, added additional in initiate children year study As FDA this treatment to of Recall six would the last the four peanut duration. the bring in approximately that children active toddlers, be age a ages of on study plan allergic When approximately safety by to supplemental generated in children
supplemental two we Written progress discuss that following Meeting with in The elements, safety study would Type two, have of to study that meeting agree month C Now the study a receipt our from key let's adequate FDA. main Viaskin made to the One, discuss Responses objectives. Peanut toddlers. and six design be had
double-blind, safety food No be both study. challenges and either we They in toddlers children, studies, placebo-controlled will will studies. months where will participation six summarize for required are, me be Let be for duration.
safety include safety XXX subjects. just about to The seven mentioned, include I total. will old As XXX the Toddler study in with about year will subjects four study children
have will with also safety FDA manner of patch data active:placebo. to X generate the studies studies previously adhesion agreed X:X Both the same VITESSE will Both for in the randomization supplemental study. Phase
product review. Now this FDA that approach the FDA the will novel we that the which received finalize the with to and review Peanut a feedback, them we is and us formal believe have FDA no well. and very is XX Viaskin best their analog, serves complex submit there practice for formal we for protocols a taking day process
picture words. a said, is worth they thousand a As
stands is Children studies shape picture and ring patches. seven COMFORT will overlay. a and COMFORT the one be and here's the the size food year four characterization safety named of optimal microgram Toddlers COMFORT peanut olds. The in the the three the So, of treatment. dose management have year of Both and to two of relief, same protein. XXX The in olds, only difference foam for to allergy, of
At back Daniel? this call point, review financial I'll to turn over the Daniel, the results. to
