Ann: Mesoblast Type A Meeting with FDA, page-233

Under the cell therapy thread I made an observation about what @pld89 picked up re single arm trials, that they seem accepted by the FDA in their recently released draft GVHD guidance. I am re-posting my additional comment as it seems it should belong here:

I contacted the company about their Type A meeting announcement on 21 Sep. It appears that they are prepared to provide more information and/or confirmation when they receive the minutes back from the FDA. They are supposed to get them back within 3 weeks of 21 Sep. Hopefully, this better flow of information continues not just over the next few months when it will be most needed, ie. when the final potency work gets done to respond to the FDA’s request for further data.