Ann: Novartis and Mesoblast Remestemcel-L Collaboration, page-671

It takes years to prepare and design a Phase 3 study. Just look at what PAR have been doing this year in developing a trial design with the FDA for OA therapy. Diligent and painstaking stuff, which they are applauded for doing to ensure that the P3 trial is as rigorously designed as possible.

The MSB trial was set up in a matter of weeks, and perhaps has been slowed and altered along the way to ensure it is as perfect as possible to ensure success, but also to save lives. What they could and perhaps should have done is after the EAP take a couple of months to design and set up before launching, and perhaps that would have ensured more "speedy enrollment" (although that may have cost lives and lead to a lot of criticism). However, ultimately it would not have changed the timelines, as we would still be where we are today, but perhaps without people calling the enrollment "slow".

Two ways to look at it I guess and can't satisfy all.