Isofol Medical: Regulatory approval for optimized study protocol - Redeye
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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.

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.
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