Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1015

Still not clear what JB is on about. He has made comments around low N values. Above statement sounds like he thinks each dot represents a subject , they don't, they represent manufacturering lots used in 001. As per bottom left hand corner. So 11 lots used in 001 , clearly the response data has been pooled from multiple subjects per lot. As such the power of data would be very varied. 1 lot may only have 2 subjects another lot may have had 8 subjects. You cannot see that JB. You cannot see survival data. And you can not see probable out comes at base line. You can not see validation data that would come from other clinical use.
It is beyond me how you could make any claim on potency assays with so little on public display .

Do you agree? the data shows a distinct trend. I would also point out that no significant improvement in two lots out of 11 is not bad considering you don't know what they may have been without treatment. Indeed it makes me question why the FDA considerd product in 001 was not standardised.