Redeye sees the finalization of the study design for a pivotal Phase IIb/III study for Aladote as a positive step. The design agreed with the FDA, the EMA, and British MHRA is in line with previously communicated plans. Our takeaways are that Pledpharma has completed regulatory interactions according to previous guidance and that none of the agencies have raised any particular hurdles regarding safety. Still, we believe PledPharma will have to carefully scrutinize safety data from the POLAR program with PledOx will before starting the Aladote trial. However, the main difference is that Aladote will be administered as a bolus dose, whereas the safety issues observed with PledOx treatment seem to present after several cycles.