4SC AG (4SC, FSE Prime Standard: VSC) has now filed with EMA its letter of intent to file for Marketing Authorization for resminostat in cutaneous T cell lymphoma (CTCL) and request the appointment of rapporteurs. Given the clear benefit provided by resminostat with respect to the lengthening of progression free survival in CTCL patients 4SC is moving forward with its Marketing Authorisation Application (MAA) process for resminostat and to initiate pre-submission interactions with EMA. 4SC remains on track to submit the MAA in Q1, 2024.
RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating
RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating
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