TSX:CSCI - Post Discussion
Post by
prophetoffactz on Aug 14, 2024 11:31am
Pediatric Diagnostic Test
The test was approved for the adult market by the US FDA and in Europe and licensed for significant upfront money. In July 2023 AEZS expected it would sign a new North American deal based on its outreach program. Gilles was on the Board of Directors and the proposed merger was announced five months later.
This is from the European Medicines Agency Report on previous limited pediatric testing:
"Overall conclusion
In all three dosing cohorts, i.e. 0.25 mg/kg body weight in Cohort 1 (C1), 0.5 mg/kg body weight in Cohort 2 (C2), and 1 mg/kg body weight in Cohort 3 (C3),
macimorelin has shown good safety and tolerability without any TEAEs or SAEs reported in the course of this trial. The PK/PD profiles are in a range expected from the adult development program. The overall characterization of macimorelin in this first pediatric trial supports the choice of a macimorelin dose of 1.0 mg/kg for the investigation in a Phase 3 trial on test validity."
Macimorelin Aeterna Zentaris, INN-macimorelin (europa.eu)
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