It does come down to detail and semantics of what is in the data submitted now to the FDA - this is MSB's release today:
The new data show that the RYONCIL product made with the current manufacturing process that has undergone successful inspection by FDA, demonstrates greater potency than the earlier generation product, providing context to its greater impact on survival.
Let's hope this is what the FDA need for approval.
I just heard Si say in the call they have enough cash to complete the Adult aGVHD trial and the HF trial and they has more cash savings in operational burn to make. Wow that is a big statement and is share price changing.
Ann: Half Year Financial Results Presentation, page-18
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