FDA ODAC Meeting Material discussion analysis, page-259

These are both excellent submissions. I urge everyone to read the comment from Dr Cass especially, which nails the issue of "mechanism of action" and the problems of requiring a randomised trial. Here is a snippet on moa:

"I also suggest the FDA consider the biological/cellular nature of remestemcel-l and to use care when applying requirements that would normally be reserved for pharmaceutical compounds. This could include, but is not limited to, in vivo determination of immunomodulatory mechanism(s) of the mesenchymal stem cell as it relates to its function in aGvHD. It would be an unrealistic expectation to request characterization of the precise mechanism of action of a treatment that is multimodal in function and administered in its natural, unmodified form. Instead, I urge the FDA to take into account the scientific consensus as it relates to the immunomodulatory function of the mesenchymal stem cell – the active ingredient of remestemcel-l."