Ann: Updated Investor Presentation, page-123

"In my understanding manufacturing is important for MSC-based cell medicine manufacturing in two clear ways - (1) the quality of the product can be determined by the manufacturing and by the quality of the cells that are started with (a medicinal cell product needs to be effective (potent) - that's the issue at present between the FDA and MSB. And (2), and this only matters when (1) is assured, the cost of the effective product can be greatly influenced by its manufacturing and cost is almost always a driver in the commercial viability of medicines."

I think you may have misunderstood the FDA concern in regards to remestemcell. It is the critical attributes of the finished product that remains in question. This they consider important because of the known variability of MSCs. Regardless of origin or manufacturing processes this is important as all drugs require a final annalases to insure that the product remains the same.

CYP claim to have the advantage as they start with the same cells. They may , however these cells will be exposed to many variables including time frozen so they potentially could perform differently through the manufacturing process which also will have variability and potential for something to go wrong.

So CQA ( critical quality attributes) is a problem for both companies. This may seem like a problem that can't be fully solved as MSCs have many different attributes that interact with each other. This is not the case as the FDA has previously stated that all they require is something not every thing.

As your GVHD trial indicated, a treatment related response would normally occur within a few days so it would also be very easy to run real world data analysis to confirm efficacy through out all treatment locations.
Efficiency is not hard to confirm when treating patients critically ill so CQA is confirmed.

To me the FDA decision to issue the CRL isn't about remestemcell L application for GVHD approval, more likely it is about the use of the therapy off label with out at least some CQA that are measured before release.

Good luck