Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-463

I simply don't understand the nature of your argument over survival data. The FDA representative says it's irrelevant to the trial because of the trial design. I provided the reference and the quote, if you have another interpretation that's up to you.

I'd point out that I'm not saying it definitely doesn't have efficacy for a GVHD, and the FDA isn't saying that either, in fact at the ODAC committee meeting they expressed the opinion that it probably does for this application. What the FDA IS saying is that the MSB trial doesn't meet the normally required standard of proof of efficacy because of inadequate trial design, lack of appropriate potency assay, missing data and some less convincing correlations and post hoc data generation. It also mirrors comments from the Canadian and Australian regulators about previous application evidence, so it isn't just the FDA who raised concerns. The FDA and the other regulators are just doing their job. It was MSB or whoever designed the trial that should carry the responsibility for the problems, they had the opportunity to do a better job but it looks like some unwise and premature judgements may have led to poor decision making.