Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-28

Hi, at a high level the FDA have three criteria for full approval. Manufacturing, efficacy and safetey. If any of these are not met to the standard required by the panel reviewing the BLA resubmission, then full approval will not be granted.

So naturally, I think if the FDA are not comfortable with manufacturing i.e. CMC items raised including MOA - then they have every right and IMO will likely issue another CRL.

The company has done a lot of work to address the CRL points on MOA and manufacturing (CMC), but the FDA did recommend another trial in children or adults - which from what I've read or heard, was raised by OTAT who raised the CMC issues.

Given what has happened with the FDA in the past, we can't rule out another CRL.

However, IMO if the FDA are satisfied with MSB's response on the MOA/CMC items raised in the CRL, then I believe efficacy and safety will not be an obstacle to approval.