A bit more on the FDA, page-57

re "If you know - x-reference your view to an actual TEVA/MSB release."

@Anjo-Roch

You may have missed my point, I have referenced a 4th reason in the original contract that is NOT to do with surrogates or any of the reasons you have stated -

If it wasn't failed surrogate endpoints, I still think it is simply a case that Teva withdrew because they were denied access to the statisticians report on the data - see clause 12 of the contract in particular the paragraph below. Note the FDA did provide comment(s), as they recommended no data be released.

If FDA provides comment(s) on the P3CHF Protocol during its initial review the incorporation of which would materially change the form and design of the P3CHF Protocol as described in this Amendment (including, without limitation, the interim analyses), then Cephalon shall either (a) work promptly with Mesoblast in good faith to address such comments ....... If the Parties agree to making changes within thirty (30) days of such meeting, they will enter into a written amendment hereto documenting the terms thereof. If the Parties fail for any reason to agree within thirty (30) days of the meeting to any such changes, then Cephalon shall be deemed to have provided a Withdrawal Notice, as defined in and subject to the Transition Procedure.