banter and General Discussion, page-8820

Insightful....not. A big and obvious 'if' in your statement. The main complaint from most holders on Hot Copper is not actually an immediate jump to conclude FDA corruption as you conclude, but in fact the obvious inconsistency of the FDA, at least from the piecemeal information we receive.

And there have been a slew of historical examples (like thousands) and evidence of poor decision making at the FDA aside from MSB. Some more commendable aspects and members of which are working hard to change shortcomings therein. For example look at the START Pilot Program which is to further accelerate the pace of development of novel drug and biological products for unmet medical needs in rare designation diseases, for obvious scale and economic reasons, that more astute aspects of the FDA have recognised. You might have heard MSB recently got a rare disease designation.

You've massively simplified an extremely complicated context for MSB's situation with the FDA, that many of us, from the evidence at hand, feel the company could indeed have done a better job on. But it's approval is clearly NOT simply down to batch consistency.

Its a novel treatment therapy, not a 'pharmaceutical or tablet'. You'd be better advised to compare it to some more recently approved novel therapies. There are plenty out there that the FDA has approved for comparison; and more relevantly quite a few that they both have approved and not approved under very questionable contexts, for comparison.

An allogeneic stem cell treatment approval is a paradigm changer and was never going to be as simple as your post suggests.