Ann: Update on BLA for Graft Versus Host Disease, page-63

I think people coming here to gloat or taunt over this decision is pretty lame.

People had rightfully hoped Si had a logical path towards approval, and had faith that the extra evidence he provided would be enough. They trusted management. Management rolled the dice.

This is a fair decision by the FDA, but it is still heartbreaking for many.

MSB has a clear path forward now, if the cells work the RCT should provide evidence for the next application. That evidence will be necessary when they bring the cells to market. This is how the process should work.

Will continue following to see what the studies show. It's still interesting science.