MSB to dispute FDA finding in Type A meeting, page-250

My theory is that MSB and FDA were not in discussions at all post-ODAC and that this blindsided MSB as they had thought the lack of contact meant approval.

Given accelerated approval is a form of conditional approval that targets unmet needs, I cannot see how we do not get accelerated/conditional approval for children. Nothing in the announcement dents this for me, as if they were going to close off the opportunity for conditional, then they would have said "adult and children" and not used the word recommended. To me, that is the FDA way of saying you're not getting adults, but let's discuss how you may get a conditional on children.

FDA do not want to be seen as green-lighting stem-cell treatment just yet with no placebo trial, but as SI points out the CLR is part of the process, and I believe FDA will be ok to give conditional. Do not think they could have done this off the bat and needed a CLR to kick-start the acceleration process.