The only thing that does is that EITHER: (a) MSB misread (due to...

The only thing that does is that EITHER: (a) MSB misread (due to inexperience, naivete, over-reading into ambiguous messages, etc., etc.) the signals that the FDA was sending; OR, more worryingly, (b) the FDA had an agenda (perhaps to make a clear example to the industry and the public that stem cells were NOT going to get an easy ride) that was not fully disclosed to MSB, and which only really came to light with the issuance of the ODAC briefing packet, with the apotheosis in the CRL.

I think it's Occam's Razor at this point. The FDA is simply out of their depth. They haven't given consistent signals, certainly that's a feature of their problem which they're making into MSB's problem.

stem cells were NOT going to get an easy ride

MSB has NOT had an easy ride! Far from it!

The lack of appropriate guidelines and protocols (because they were drug focussed) meant MSB and Teva (then partners) had to show the FDA how it's done and they did it collaboratively. Progress has been grindingly slow. The shared intention was to eliminate the cowboys who DO want an easy ride. Please read back on this. SI has been an adviser on this. I spoke with him years ago about the regulatory barriers, and he was well aware of the issues.

But you cannot plan for capriciousness. I've seen this fear and not reason-based mentality in the public service firsthand but naturally I cannot go into it. It also exists in private enterprise but they have other tendencies, viz. to be ultra risky, and that's where the rogue operators are.

The FDA simply do not understand what they have here and they are in danger of making utter goats of themselves and being responsible for needless deaths. (Not that it's a problem in the Trump era, things have become so warped about conflict of interest and corruption that 200k+ deaths do not register).

There are signs that the America First mentality could be behind it and stalling for a competitor to catch up, but that's only a possibility. We cannot absolutely rule it out with this administration. Unlike Australia the public service is highly politicised. The FDA should be independent but there are no guarantees that this is what is occurring here. It's murky.