Taken from October 2017 investor presentation. Could be the infrastructure to support the following-
Trofinetide development program
Investments ongoing before commencement of Phase 3 trial:
Conclude optimization of API manufacturing process for commercial supply
Conclude stability testing and analytical validation of to‐be‐marketed liquid drug formulation
Conduct non‐clinical toxicity study in second species with 6 months’ dosing, required for NDA and Phase 3 trial with longer dosing
Schedule manufacturing to supply the Phase 3 trial
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