Efficacy established.. Mode of action, MSB seems to be very confident however not a necessary condition for approval. Manufacturing quality, MSB is also confident however FDA will require proof of ongoing quality, this is the only ongoing discussion with MSB and the FDA. Consider that each donner producers around 400 treatments I hardly think giving around 8 or 10 patients that other wise could not access the therapy due to cost is much of a problem. Set a minimum standard based around inflammation markers and then you have 390 treatments ready to market.
This problem is not hard to overcome and satisfying the FDA.
Good luck all.
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