The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-1376

NZT
This was in the "FDA Outlines Pathway to Accelerated Approval for Monepantel in MND"

"The FDA also advised that there were no minimum requirements for the number patients and study sites located
in the US paving the way for the adaptive Phase 2/3 clinical study to be a global study. Clinical sites and patients
from Europe and Australia will be utilised leading to decreased recruitment timelines and allowing PharmAust to
also seek approval from the European Medicines Agency (EMA) and Australia’s Therapeutic Goods
Administration (TGA) following completion of the adaptive Phase 2/3 study."

TC