PAR. SP, page-831

This has been addressed by Donna in a webinar recently, I can’t recall if it was in the Q and A or a slide. Basically, the fda wanted to test if there is a lower dose with equal effect and safety as the 2mg/kg twice weekly. What I took from that is, there is no question over the 2mg/kg doses effect or safety, rather…. Is there a lower dose with comparable effect and safety.

in a clinical trial, you don’t subject trial particapants to a dose in an unproven drug unless you have to (in this instance they will be in stage2) so 2mg was left out of stage 1, as the hypothesis was not to test its (2mg) effect and safety (as that has been done/established in 005, 008 phase 2b)