The way I see FDA's major concern, demonstration of consistent batch to batch effectiveness , they are not convinced that MSB batch testing demonstrates a consistent product. Problem is if MSB were to test this in a clinical setting, some patients would have to receive substandard product that may result in death.
I believe that the problem of batch consistency is reasonably easy to monitor and would address the concerns of the FDA . Run a patient data base with key outcomes and monitor for a period of time. The solution is that simple and is what these meetings are all about.
Common sence will prevail,
good luck.
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