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09:46
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Originally posted by RickyH:
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The problem, I think, that is argued by the FDA is, how can you ensure your product will work every time if you don't know what part of it is working?
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In the simplest terms, if sick people get better, if trials meet endpoints, you can know its consistent enough. You cant have good trial outcomes if the product is all over the place. Another trial will hopefully confirm that beyond debate. There are potency essays/markers. I believe MSB have put forth a "cartoon" on how, in MSB view, how its believed to work. This MOA has not been proven without doubt, yet there are plenty of drugs being sold that have no known MOA.
(20min delay)