Ryoncil: ODAC/FDA Meeting Discussion, page-849

Actually from reviewing of MSB thesis/proposal. I would say that MSCs are not to be used with anti-TNFalpha monoclonal antibody. as removal of TNF would deem these cells less effective.

The final comment about genomic profile of the cell LOT is expected. HOWEVER, the patients will have to pick up the cost (ie: increase the price tag) without necessarily confirm that the cell efficacy is more consistent, as there is currently no evidence to support this hypothesis. BUT, I agree, scientifically yes, performing a genomic profile of the cells will likely teach us a lot of new insights into the development of these cells as the number of passages increase. It is a good idea, especially when we want to move to a 3D bioreactor process, where it is impossible to track the number of passages.

Overall, the Morning session went REALLY WELL. I think SI addressed most of the concerns raised by the panel. I believe SI will handle the afternoon session as equally well. Though I may have to go off now and wake up later to tune in for the voting.