MSB to dispute FDA finding in Type A meeting, page-605

Like any government department, the directive can change. The scientists at the coal face may have been giving policy advice that could be overruled by someone higher up the chain, or there could be a directive to the organisation as a whole to increase the emphasis of RCTs, there are a lot of possible reasons on the FDA side of things where they may have changed their mind.

On the Mesoblast side, it's possible they misread the FDA's feedback, or played down certain aspects of the trial. When Dr Itescu was asked on the investor call "is the FDA obligated to grant Mesoblast a type A meeting?" he answered "we believe so". Since that's not the case, and the FDA isn't obligated to grant them a type A meeting, we know that their confidence (at least their facade of confidence to shareholders) probably outpaces their standing with the FDA.

You can't really blame Mesoblast for a bit of overconfidence though, they were much more measured than HC posters on the approval chance for GVHD

What they do next will tell us a lot about the exec team's ability to guide the company, and if they are ready to step out of the small pond and swim around with the big fish.