The latter stipulation is that additional safety monitoring will...

The latter stipulation is that additional safety monitoring will need to occur during the Phase 3 and the safety protocols will need to be rigorously laid out. This may be no less than Prana were going to do already and there is good evidence from other trials that there are unlikely to be issues. The question is what HD dosage are they intending for the trial relative to what has gone on in the past, seems like it may be going up. On the additional animal toxicity one, this wouldnt be a difficult piece of work and setting up for a Phase 3 takes time, so likely it could be run in parallel with any early establishment work without substantively changing the crtical path for the Phase 3.