A bit more on the FDA, page-59

@Anjo-Roch

If it is pie-in-the-sky, it is also pie-in-the-sky written clearly in the very same contract you are looking at. Note, the point I am making paints a far better outcome for Mesoblast than that provided by surrogate failures.
Here is the sequence :-
1. FDA announce no data be released including surrogates (this is true, and the CEO has stated that surrogate data was not released - only once and before Teva left)

2. Teva and Mesoblast were unable to agree an amendment and so they walked using point 12 of the contract because they could not see the data, and they came to no mutually agreeable alternative.

That is not a slur on Mesoblast, Teva took their chance and got out of the process. Maybe it was a bone-headed decision, time will tell.

My only concern with the above theory has been Mesoblast's inability to simply clear up the issue. Maybe they can't for privacy reasons.