Hi Pete! In order to get it approved as breakthru

Hi Pete! In order to get it approved as breakthru - they will have to prove safety, tolerability and efficacy. The current safety trial will not apply to pediatric population. They would have to do another phI but could speed it up into combined phI/II and go from there. They would have to proceed with adherence to all of the fda regs - which means carefully choosing population and monitoring and accounting for every dose - so no 'free for all' in dispensing. Along with many others, I have believed they would use the RB as their most rapid path to initial marketing of K.