Ann: Update on BLA for Graft Versus Host Disease, page-669

this kind of nonsense is commonly spouted on HC

as far as the FDA is concerned there is insufficient evidence MSCs provide a significant benefit

an RCT is the gold standard to demonstrate efficacy

an RCT doesn't have to be testing MSCs against placebo, in fact a more compelling case is made if MSB can show significant benefit over current standard of care

if the benefit of MSCs is so substantial then only a small number of patients would be required to demonstrate statistical significance (look up how to adequately power a study, if you need more info)

the FDA pointed out that MSBs claims of dismal survival in GVHD were cherry picked from one particularly dire study

if MSB was so confident in the benefit of stems they could have run an RCT like was recommended by the FDA

RCTs are run in children all the time.

MSB tried to play the "wont somebody think of the children" card, MSB ran a single arm study rather than an RCT, MSB played stupid games and won stupid prizes