Ansøgeren mener, at den originale strategi om at bygge bro samt den signifikante mængde leverede bekræftende effekt - og sikkerhedsdata for cancerpatienter viser, at Rapinyl bestemt har en positiv risk/ benefit- profil.
The Applicant believes that the original bridging strategy plus the significant body of confirmatory efficacy and safety data in cancer patients provided demonstrate that Rapinyl does indeed have a positive benefit-risk profile.