AA, page-7

I think this is really big. Admittedly they are talking Gene therapy but it is not a big leap to suggest the same approach will be used with cell and gene therapy. In the context of GvHD I thought the following was really interesting. 'There are plenty of biomarkers that have been used over the years' that were not qualified, he told the workshop. 'As long as you can show that you have a biomarker that can be measured accurately and reproducibly, we don’t necessarily always need all of the additional work that gets to qualification,' he said. Of course the accurately and reproducibly was our problem with the Phase III GvHD study, but if as Management says MESO has solved this issue through improving the QC on the reagents then we may indeed get approval by the end of the year as SI expects.

Lastly the discussion on rare diseases and confirmatory studies was really encouraging. 'Confirmatory trials are required as part of the accelerated approval pathway, and typically are randomized controlled trials to verify the clinical benefit. But because these are such small populations with fatal diseases, how these trials are conducted will need to be tweaked given that it would be unethical to run placebo-controlled trials in some of these populations.'