SEB har mod betaling udarbejdet denne analyse af FluoGuide:
At SEB’s Nordic Seminar, FluoGuide CEO Morten Albrechtsen clearly laid out the equity story and discussed the path to approval and reimbursement. We were particularly interested in his thoughts about the need for flexibility in the clinical programme to be able to demonstrate clinical efficacy, superiority, and methods of use, in order to maximise reimbursement. We were also encouraged that FluoGuide’s clinical program continues to be on track.
Cytalux is a case study that illuminates the bar for success
We had an interesting discussion about what the bar for success is for FG001, and here the recent approval of Cytalux (OTL38) for ovarian cancer is instructive, as the FDA required that it cross a threshold of 10% improvement in positive predictive value. This is a very low bar for approval, in our view. Cytalux delivered a 27% improvement. We note that OTL38 targets the folate receptor, which has broader distribution than uPAR, and that 20% of patients had normal tissue removed as well. Importantly, however, the bar for success also relates to reimbursement, and there we agree with management that demonstrating improvement in patient outcomes would greatly increase pricing power
Generalt om Commissioned Research: Bemærk, at man bør se bort fra eventuelle kursestimater i såkaldt commissioned research, og den underliggende analyse skal også tolkes med forsigtighed, da negative aspekter ikke nødvendigvis fremhæves.
Få vores øvrige investeringsnyheder direkte i din indbakke. Tilmeld dig vores gratis daglige nyhedsbrev her:
Få dagens vigtigste
økonominyheder hver dag kl. 12
Bliv opdateret på aktiemarkedets bevægelser, skarpe indsigter
og nyeste tendenser fra Økonomisk Ugebrev – helt gratis.
