Quote Originally Posted by Jim View Post
Yes, a major difference in time!

When the 27 patients are randomized to the 3 groups (cell transplantation + walking/rehab, cell transplantation + lithium + walking/rehab, walking/rehab only), the therapy will then be available.
I disagree with that Jim. I would be gobsmacked if the FDA would green light compassionate use whilst the 3 groups are receiving their interventions. They would require safety data from the first US-treated cohort before considering any kind of compassionate use. Are you being overzealous here?