MSB - Panic > Averaged down > Entry point., page-20

A smart person would average in

Firstly, gvhd will be approved based on the 3 studies already completed
secondly MSB have a lot more products in the pipeline with a bigger market than gvhd with trials designed around how the FDA would like.

given gvhd has received a CRL and now a type a meeting will ensue, MSB will be going over their data with what the FDA would like for future reference which sets it up again for success

this CRL is NOT a rejection, it's a request for a double blind placebo controlled study in adults, because to do one in children is unethical and will be impossible given the participant's would refuse anything other than the product (along with ethical issues in potentially letting kids die)
but the FDA doesn't seem phased about letting kids die so who knows, really, the FDA has does a 180 on their own advise
this is why they hire professionals in the ODAC committee...

as always, not advise

edit: it's always been MSBs intent to proceed with a double blind placebo controlled trial in adults, post approval, as mentioned in the ODAC committee