yes, in detail.
but I try to focus on what the FDA is saying... and the FDA dismisses a lot of what MSB are saying, so I think they will have to agree to disagree on manufacturing. To me that is not a deal breaker... MsB and the FDA will find a way to build a bridge over MsB’s massive moat and get over this manufacturing issue to get approval.
bridge = confirmatory trial or labelling
FDA ODAC Meeting Material discussion analysis, page-313
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