I understand it in general terms but thank you because it showed me I wasn't specific enough
we know it works. The question that the Fda seems to be asking is about potency consistency between doses.
@MelbourneBoy put it better - is the outcome variance a result of variance in patients or variance in the potency in doses and how does msb prove each dose is equally potent.
otherwise as an extreme example a patient may die simply because their dose wasn't as strong as another's.
MSB to dispute FDA finding in Type A meeting, page-43
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