I'll just post some of my thoughts on OTAT. I don't expect you to answer any of these - but, feel free if you are inclined
As per the ODAC 9-1 where FDA decided to overturn the ODAC recommendation/ vote. My concern is that this may get into an academic discussion OTAT; all theory based.
We know that MOA is not required to be fully explained/ understood for a product to be FDA approved. So what is the requirement for the potency essays - where would the FDA/ OTAT draw the line?
When does real life data come into play e.g. data from the C19 ARDS <65 patients? Data from Temcell?
How and where is potency measured at cell levels vs overall outcome?
I still have faith in the Mesoblast science, but I have learnt not to trust the FDA - as their decision making is too opaque for my linking
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