FDA ODAC Meeting Material discussion analysis, page-337

Another aspect that has not been discussed much on here is cost.

If we assume efficacy and safety parameters are (or will be) ticked then the remaining questions relating to QA and manufacturing are (one would think) attainable but potential delays. My point is that they are attainable - process driven it looks likely.

As such:

1. Delays potentially: Loss of life.
2. Increased cost: Costs would of been discussed prior to today and QA and manufacturing costs will increases through this line of questioning. The solution becomes higher in costs making it less attainable.

The FDA will know that by 'fort knoxing' Mesoblast it takes it further away from the people that need it (as I said if they agree with the sentiment of efficacy and safety above). It's a balancing act with children's lives on one side of the ledger. Tough job!