MSB to dispute FDA finding in Type A meeting, page-398

Yes, I agree. Hopefully, they will set aside enough for SR-aGVHD once approved and go into manufacturing overdrive for ARDS. This is their immediate limitation regardless of what indication they get approval for, but it has to be addressed without overcommitting beforehand ( a delicate balancing act.)

I can't help but wonder if the FDA felt that MSB were trying to force their hand because of the ethical implications of rejecting this first approval. We all thought it a strategic master stroke by SI and team to go for such an indication first, albeit a small market, in order to open the doors for stem cell treatments, but the FDA may have thought otherwise. I was as shocked as anyone at their response, and I hope it is just a delay at worst - part of "a process" as Fred Grossman stated - and the FDA are just considering their options for approval for the reasons I outlined before.

I feel for the parents, and I hope MSB will support them with product throughout the process, however long it takes. I have a son who had open-heart surgery at 18 months of age, so my first interest in Stem Cells was their potential use in life-saving cardiac treatments - which is what drew me to MSB in 2015.

I hope for everybody's sake that there isn't something more sinister going on at the FDA. At the end of the day, it could go either way, and we are all now trying to work out what they are playing at after Friday's bombshell. The central issue here isn't about the science - we have plenty of scientific and anecdotal proof that MSB is the real deal. What it really boils down to can be summarised in two words - FDA integrity. Are they trying to preserve their integrity through a rigorous scientific process, or is it really just an anti stem cell, pro big pharma agenda? (because there's plenty of anecdotal evidence for that too)

I guess we'll know eventually, but irrespective, I have no doubt that MSB will succeed in the end - in other markets if not the US - and their treatments will be available to all children globally, as well as adults, for a number of indications. I have great confidence in SI and team to get this done.