Isofol Medical: Regulatory approval for optimized study protocol - Redeye

Redeye briefly comments on Isofol’s announcement that the German regulatory authority BfArM has approved an optimized design for the ongoing phase Ib/II study with arfolitixorin. We are encouraged by the addition of a control arm versus leucovorin, broadened inclusion criteria, and expansion to multiple study centers, which together should strengthen the clinical evidence package and support faster recruitment.

Länk till analysen i sin helhet: https://www.redeye.se/research/1159838/isofol-medical-regulatory-approval-for-optimized-study-protocol?utm_source=finwire&utm_medium=RSS