"tantamount to a rejection" in that it is not approved for...

"tantamount to a rejection" in that it is not approved for marketing, sure. No argument with that and I'm not happy with the outcome.

They have asked for "further evidence of the effectiveness of remestemcel-L for SR-aGVHD" in the form of a randomised placebo controlled trial. They acknowledge this is not desirable in children so have included the option of adults in the requested study. This could be construed of a rejection of MSB's strategy to get an approval based on the lowest hanging fruit (putting aside that the patients are also some of those most in need). They have not "rejected" the appearance of effecacy in the single arm trial, they have said (meeting pending) that they insist on the higher hurdle of a randomised controlled trial (which is what they are rightly used to insisting upon). So the reality is that the situation is fluid, the final outcome is up in the air and we appear to be a good fit for the accelerated approval program. We are not "reapplying later" as stated in your generic two sentence definition.

If another poster wants portray remestemcel-L (rather than the "initial application") as "rejected" and I challenge that why do you feel the need to wade in, tell me I'm wrong refer to me as a naive, optimistic nut head. "Approved if you meet condition X" is not the best description but you could always clarify rather than throw punches. I generally favour pistols at dawn.