Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-696

I believe approval is highly likely based on 3 very important points:

1. The safety profile of Rem-l is similar to placebo with no concerns across multiple trials and the FDA have accepted this (did not require ODAC panel to vote on this aspect as they understand there are no current safety concerns).
2. There is a significant unmet need for the treatment in children with steroid-refractory GvHD as there is currently no approved treatment.
3. The product is proven to be effective in the pediatric cohort as supported by multiple trial data and accepted by the ODAC panel 9-1 vote on efficacy.

The FDA did raise valid concerns about manufacturing consistency however msb responded well and have been working with the FDA on best practice approaches to ensure this. Also as others have reiterated a placebo controlled trial on children is not possible due to how unethical it is.

I do see the FDA wanting a P4 trial in adults so that a label extension can be made if successful to get patients of Ruxolitinib (for those who don't know it has a long list of terrible side effects).