Hi Martin,Great points and sorry for the slow reply, I had to...

Hi Martin,

Great points and sorry for the slow reply, I had to sit down and read the 2020 remestemcel l trial again.

interestingly (I overlooked it last time) there is a supplementary table with a few reference to how the control was decided upon. not sure why they weren’t referenced in the main article as it’s a key point for a single arm trial. One of them being this one:
https://www.astctjournal.org/article/S1083-8791(19)30449-5/fulltext

it’s a well written paper that looks at response to second line therapies and does seem to justify a control OR of 45% (perhaps less actually).

To make it plain and clear - after a couple of days working out how the new data fits in I am once again convinced that this should be approved once. The manufacturing issues are sorted.

thanks all for the discussion and clarification!