That is what is currently required by the FDA for traceability ,...

That is what is currently required by the FDA for traceability , safety, potency etc., ….our process allows for multiple donors to be stored in the Master Cell Bank. We have shown how we can control minimum levels of T cell suppression , from multiple individual donors, and still achieve a consistent product which is pure , safe , potent and traceable. How will the Cynata process adapt ? I note that our results have been shown to be superior to MSC-FFM used in Germany under special licence, which is a pooled donor product by the way… arguably because of superior potency selection, priming and harvesting techniques. We have the long term data to prove it. The problem for Cynata is “one size fits all” is not a fully optimised solution. I believe Yamanaka understood the weakness in a “one donor” strategy which is why he researched creating MCBs from a variety of population sub sets . Pluripotent may be great for manufacturing costs but does not optimise the needs of a specific patient populations…not to mention the risk of tumours. I don't suppose you have looked at the hazard ratios applying a female donor cells to a male recipient or why the FDA will not accept Japanese approved MSCs for use in the USA.
This debate will be pretty superfluous after authorisation. Whilst Mesoblast may be able to tweak efficacy in non responders by increasing dose or extending the length of treatments , no one has come close IMO in a phase 3 trial, to our results in severe grades. The obfuscation tactics will not work with me ..it looks as though the FDA has finally got its act together. Nice try though. OP



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