That’s just the reality of working with CDMOs - things can and do go wrong, especially in terms of batch release. For me it’s quite positive that they’ve identified that it’s a technical issue with one of their assays, and reading between the lines it sounds like hopefully one that can be fixed up fairly rapidly. Doesn’t sound from the ANN that there are major concerns about product quality at this stage.
Obviously any delays are frustrating, but that’s the nature of the industry…
Ann: Further update on PAT-DX1 GMP manufacturing run, page-22
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