We are waiting for the potency assays on the Ryoncil inventory which is being tested to prove that it matches the product used in the GVHD001 trial.If the potency assay matches then FDA has told Meso that Ryoncil can be approved. So I would regard those results as market sensitive and they should be released to the market when they are finalized. Pharmagang on h c said SI told him at the Bell Potter conference that SI expected these assay results in mid January - but SI has been overly optimistic on timelines in the past.I don’t have any special insight as to how long these results will take, but Meso expects to hold a meeting with FDA for aGvHD this quarter, so the potency assay work needs to be finished between now and March 31st.SI was very confident that the potency assays would match up as the cells were all manufactured by Lonza using the same manufacturing process.
A
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