hitting a sore spot eh? The consistency issue is an MSC platform killer until it is sorted.
FDA have said No to the proofs and you just do not get it.
why don't you ask MSB about it's Captial Raise funded bioreactor oven? among other things like parting the red seas it was also to ease the issue of one bag of cells not being able to be proved to do as the next bag of cells.
and don't lecture me on MOA eat al. the issue here is not just on efficacy - it is a CMC issue that all drugs and therapies must reach. even I know that with generic viagra I get the same therapeutic does - that is due to GMP not RWE lol
Cell Therapy News/Articles, page-17043
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